Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
Study NCT ID:
NCT03529461
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2018-05-03
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgedeon@bristolhospital.org', 'phone': '8605853339', 'title': 'Makram Gedeon, MD', 'organization': 'Bristol Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1800 seconds (30 minutes)', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine\n\nRescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental', 'description': 'Intervention: Non invasive positive pressure nasal mask connected once patient is sedated\n\nNIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an Oxygen Desaturation Event ≤ 94%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine\n\nRescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Intervention: Non invasive positive pressure nasal mask connected once patient is sedated\n\nNIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).', 'description': 'Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an Oxygen Desaturation Event < 90%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine\n\nRescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Intervention: Non invasive positive pressure nasal mask connected once patient is sedated\n\nNIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).', 'description': 'Percentage of participants who develop a peripheral oxygen saturation event \\< 90%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Participants With Oxygen Desaturation < 90%', 'description': 'Rescue NIPPV: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O. If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 minutes following a desaturation event < 90 %', 'description': 'We used non-invasive positive pressure ventilation (NIPPV) as a first rescue maneuver in control patients who developed an oxygen desaturation less than 90 % and reported on the percentage of participants who responded. The rescue was considered successful with recovery of oxygen saturation more than 90 % within 3 minutes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We report on the response of 8 participants in the control group who had an oxygen desaturation event less than 90 %'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Intervention: nasal cannula 6L O2 + non invasive positive pressure (NIPPV) nasal mask not connected to machine\n\nRescue NIPPV via nasal mask: If oxygen desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 saturation is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If oxygen saturation \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If saturation does not increase \\> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'Intervention: NIPP placed on patient. Positive pressure applied once patient is sedated\n\nNIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue NIPPV maneuver attempted (including adjustments in pressure) and O2 saturation is not above 90 % within 3 min of starting NIPPV, endoscope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If saturation \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If saturation does not increase \\> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment began on 4/25/2017 and ended on 4/2/2018.', 'preAssignmentDetails': '208 patients assessed for eligibility:\n\n* 56 patients enrolled\n* 152 patients excluded (reasons: 127 not meeting inclusion criteria or no show for procedure, 6 patients declined to participate, 19 patients excluded because of early trial closure)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine\n\nRescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'Intervention: Non invasive positive pressure nasal mask connected once patient is sedated\n\nNIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.\n\nSecondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \\> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '36.5', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-23', 'size': 677378, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-05-08T16:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-08', 'studyFirstSubmitDate': '2018-05-03', 'resultsFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-08', 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With an Oxygen Desaturation Event ≤ 94%', 'timeFrame': 'Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).', 'description': 'Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%'}, {'measure': 'Percentage of Participants With an Oxygen Desaturation Event < 90%', 'timeFrame': 'Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).', 'description': 'Percentage of participants who develop a peripheral oxygen saturation event \\< 90%.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV', 'timeFrame': '3 minutes following a desaturation event < 90 %', 'description': 'We used non-invasive positive pressure ventilation (NIPPV) as a first rescue maneuver in control patients who developed an oxygen desaturation less than 90 % and reported on the percentage of participants who responded. The rescue was considered successful with recovery of oxygen saturation more than 90 % within 3 minutes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['severe obesity', 'non-invasive positive pressure ventilation', 'endoscopy', 'hypoxia', 'bariatric surgery', 'sedation', 'adverse events', 'BMI', 'anesthesia', 'complications'], 'conditions': ['Severe Obesity', 'Hypoxia']}, 'referencesModule': {'references': [{'pmid': '16645462', 'type': 'BACKGROUND', 'citation': 'Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.'}, {'pmid': '23624448', 'type': 'BACKGROUND', 'citation': "Arakawa H, Kaise M, Sumiyama K, Saito S, Suzuki T, Tajiri H. Does pulse oximetry accurately monitor a patient's ventilation during sedated endoscopy under oxygen supplementation? Singapore Med J. 2013 Apr;54(4):212-5. doi: 10.11622/smedj.2013075."}, {'pmid': '24976715', 'type': 'BACKGROUND', 'citation': 'De Palma GD, Forestieri P. Role of endoscopy in the bariatric surgery of patients. World J Gastroenterol. 2014 Jun 28;20(24):7777-84. doi: 10.3748/wjg.v20.i24.7777.'}, {'pmid': '27272580', 'type': 'BACKGROUND', 'citation': 'Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.'}, {'pmid': '26111263', 'type': 'BACKGROUND', 'citation': 'Fouladpour N, Jesudoss R, Bolden N, Shaman Z, Auckley D. Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. Anesth Analg. 2016 Jan;122(1):145-51. doi: 10.1213/ANE.0000000000000841.'}, {'pmid': '19173756', 'type': 'BACKGROUND', 'citation': 'Gay PC. Complications of noninvasive ventilation in acute care. Respir Care. 2009 Feb;54(2):246-57; discussion 257-8.'}, {'pmid': '25516819', 'type': 'BACKGROUND', 'citation': 'Gomez V, Bhalla R, Heckman MG, Florit PT, Diehl NN, Rawal B, Lynch SA, Loeb DS. Routine Screening Endoscopy before Bariatric Surgery: Is It Necessary? Bariatr Surg Pract Patient Care. 2014 Dec 1;9(4):143-149. doi: 10.1089/bari.2014.0024.'}, {'pmid': '24574597', 'type': 'BACKGROUND', 'citation': 'Goudra BG, Singh PM, Penugonda LC, Speck RM, Sinha AC. Significantly reduced hypoxemic events in morbidly obese patients undergoing gastrointestinal endoscopy: Predictors and practice effect. J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):71-7. doi: 10.4103/0970-9185.125707.'}, {'pmid': '27885537', 'type': 'BACKGROUND', 'citation': 'McVay T, Fang JC, Taylor L, Au A, Williams W, Presson AP, Al-Dulaimi R, Volckmann E, Ibele A. Safety Analysis of Bariatric Patients Undergoing Outpatient Upper Endoscopy with Non-Anesthesia Administered Propofol Sedation. Obes Surg. 2017 Jun;27(6):1501-1507. doi: 10.1007/s11695-016-2478-4.'}, {'pmid': '27101493', 'type': 'BACKGROUND', 'citation': 'Opperer M, Cozowicz C, Bugada D, Mokhlesi B, Kaw R, Auckley D, Chung F, Memtsoudis SG. Does Obstructive Sleep Apnea Influence Perioperative Outcome? A Qualitative Systematic Review for the Society of Anesthesia and Sleep Medicine Task Force on Preoperative Preparation of Patients with Sleep-Disordered Breathing. Anesth Analg. 2016 May;122(5):1321-34. doi: 10.1213/ANE.0000000000001178.'}, {'pmid': '27004254', 'type': 'BACKGROUND', 'citation': 'Saunders R, Erslon M, Vargo J. Modeling the costs and benefits of capnography monitoring during procedural sedation for gastrointestinal endoscopy. Endosc Int Open. 2016 Mar;4(3):E340-51. doi: 10.1055/s-0042-100719.'}, {'pmid': '23992025', 'type': 'BACKGROUND', 'citation': 'Slagelse C, Vilmann P, Hornslet P, Jorgensen HL, Horsted TI. The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: a randomized study. Scand J Gastroenterol. 2013 Oct;48(10):1222-30. doi: 10.3109/00365521.2013.830327. Epub 2013 Sep 2.'}, {'pmid': '24292821', 'type': 'BACKGROUND', 'citation': 'Soto RG, Davis M, Faulkner MJ. A comparison of the incidence of hypercapnea in non-obese and morbidly obese peri-operative patients using the SenTec transcutaneous pCO(2) monitor. J Clin Monit Comput. 2014 Jun;28(3):293-8. doi: 10.1007/s10877-013-9534-6. Epub 2013 Nov 29.'}, {'pmid': '22136773', 'type': 'BACKGROUND', 'citation': 'Wani S, Azar R, Hovis CE, Hovis RM, Cote GA, Hall M, Waldbaum L, Kushnir V, Early D, Mullady DK, Murad F, Edmundowicz SA, Jonnalagadda SS. Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures. Gastrointest Endosc. 2011 Dec;74(6):1238-47. doi: 10.1016/j.gie.2011.09.006.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.', 'detailedDescription': 'Patients being evaluated for bariatric surgery often undergo preoperative upper endoscopy. Patients with obesity are at increased risk for sedation related adverse events during endoscopy. The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation in patients with severe obesity undergoing upper endoscopy. The study was a randomized controlled trial that assessed the effectiveness of NIPPV in patients undergoing upper endoscopy. Patients were randomized into experimental group NIPPV or control group. Primary endpoints were desaturation events (SpO2 \\<=94%) and desaturation events requiring intervention (SpO2\\<=90%). A secondary endpoint was the use of NIPPV to rescue patients who developed a clinically significant desaturation event.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight loss surgery patients undergoing preoperative upper endoscopy\n* BMI 40-60\n\nExclusion Criteria:\n\n* Pregnant patients\n* Previous weight loss surgery or stomach surgery\n* BMI \\> 60 and BMI \\< 40\n* Active smokers\n* Patients with a history of recent URTI (Upper Respiratory Tract Infection) within the preceding 2 weeks\n* Lung disease, COPD asthma, cystic fibrosis, sarcoidosis\n* Baseline O2 saturation less than or equal to 94%\n* Exclude substance abusers (active alcohol abuse, benzodiazepine abuse, and active illicit drug use)'}, 'identificationModule': {'nctId': 'NCT03529461', 'briefTitle': 'Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Bristol Hospital'}, 'officialTitle': 'Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures', 'orgStudyIdInfo': {'id': '20170730'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)', 'interventionNames': ['Device: Rescue non-invasive positive pressure ventilation through nasal mask', 'Other: Secondary rescue maneuvers']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)', 'interventionNames': ['Device: Non-invasive positive pressure ventilation through nasal mask', 'Other: Secondary rescue maneuvers']}], 'interventions': [{'name': 'Non-invasive positive pressure ventilation through nasal mask', 'type': 'DEVICE', 'description': 'Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly', 'armGroupLabels': ['Experimental']}, {'name': 'Rescue non-invasive positive pressure ventilation through nasal mask', 'type': 'DEVICE', 'description': 'If desaturation below 90 %, nasal cannula removed and non invasive positive pressure nasal mask connected to machine: Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly', 'armGroupLabels': ['Control']}, {'name': 'Secondary rescue maneuvers', 'type': 'OTHER', 'description': 'If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \\> 90 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \\> 90 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Bristol', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bristol Hospital', 'geoPoint': {'lat': 41.67176, 'lon': -72.94927}}], 'overallOfficials': [{'name': 'Makram M Gedeon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bristol Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical director of bariatric surgery program, principal investigator', 'investigatorFullName': 'Makram Gedeon, MD', 'investigatorAffiliation': 'Bristol Hospital'}}}}