Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT04331366
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2020-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffrey.miller@emory.edu', 'phone': '404-778-7200', 'title': 'Jeffery Miller, MD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for adverse events on the day of the intervention beginning just prior to treatment with the mouthpiece through 15 minutes after the cessation of PEEP therapy, for a total of up to 30 minutes.', 'description': 'Participants were assessed for the following adverse events:\n\n* Decreased oxygen saturation\n* Increased respiratory rate\n* Increased heart rate\n* Low blood pressure\n* Increased work of breathing\n* Worsening arterial blood gases (if available)\n* Inability to tolerate the mouthpiece', 'eventGroups': [{'id': 'EG000', 'title': 'GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Decrease in oxygen saturation after cessation of PEEP therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Oxygen Saturation by Pulse Oximetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '92', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minute 5', 'categories': [{'measurements': [{'value': '93.5', 'spread': '0.707', 'groupId': 'OG000'}]}]}, {'title': 'Minute 10', 'categories': [{'measurements': [{'value': '94', 'spread': '1.414', 'groupId': 'OG000'}]}]}, {'title': 'Minute 15', 'categories': [{'measurements': [{'value': '94', 'spread': '1.414', 'groupId': 'OG000'}]}]}, {'title': 'Minute 30 (15 minutes post-treatment)', 'categories': [{'measurements': [{'value': '92.5', 'spread': '0.707', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'Pulse oximetry is a way to assess whether or not a patient needs help breathing. Oxygen saturation levels for healthy individuals are 95% and above.', 'unitOfMeasure': 'percentage of oxygen saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.5', 'spread': '0.707', 'groupId': 'OG000'}]}]}, {'title': 'Minute 5', 'categories': [{'measurements': [{'value': '20', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minute 10', 'categories': [{'measurements': [{'value': '18', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minute 15', 'categories': [{'measurements': [{'value': '17', 'spread': '1.414', 'groupId': 'OG000'}]}]}, {'title': 'Minute 30 (15 minutes post-treatment)', 'categories': [{'measurements': [{'value': '18.5', 'spread': '0.707', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'The number of breaths per minute was assessed before treatment, during treatment, and 15 minutes after the end of treatment.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '84.5', 'spread': '17.678', 'groupId': 'OG000'}]}]}, {'title': 'Minute 5', 'categories': [{'measurements': [{'value': '87.5', 'spread': '17.678', 'groupId': 'OG000'}]}]}, {'title': 'Minute 10', 'categories': [{'measurements': [{'value': '90.5', 'spread': '20.506', 'groupId': 'OG000'}]}]}, {'title': 'Minute 15', 'categories': [{'measurements': [{'value': '86.5', 'spread': '16.263', 'groupId': 'OG000'}]}]}, {'title': 'Minute 30 (15 minutes post-treatment)', 'categories': [{'measurements': [{'value': '86.5', 'spread': '14.849', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'Heart rate, in beats per minute, was assessed before treatment, during treatment, and 15 minutes after the end of treatment.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE.'}], 'classes': [{'title': 'Baseline Systolic', 'categories': [{'measurements': [{'value': '152.5', 'spread': '31.820', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Diastolic', 'categories': [{'measurements': [{'value': '65', 'spread': '7.071', 'groupId': 'OG000'}]}]}, {'title': 'Minute 5 Systolic', 'categories': [{'measurements': [{'value': '155', 'spread': '21.213', 'groupId': 'OG000'}]}]}, {'title': 'Minute 5 Diastolic', 'categories': [{'measurements': [{'value': '72.5', 'spread': '10.607', 'groupId': 'OG000'}]}]}, {'title': 'Minute 10 Systolic', 'categories': [{'measurements': [{'value': '150', 'spread': '21.213', 'groupId': 'OG000'}]}]}, {'title': 'Minute 10 Diastolic', 'categories': [{'measurements': [{'value': '70', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minute 15 Systolic', 'categories': [{'measurements': [{'value': '145', 'spread': '21.213', 'groupId': 'OG000'}]}]}, {'title': 'Minute 15 Diastolic', 'categories': [{'measurements': [{'value': '67.5', 'spread': '3.536', 'groupId': 'OG000'}]}]}, {'title': 'Minute 30 (15 minutes post-treatment) Systolic', 'categories': [{'measurements': [{'value': '152.5', 'spread': '24.749', 'groupId': 'OG000'}]}]}, {'title': 'Minute 30 (15 minutes post-treatment) Diastolic', 'categories': [{'measurements': [{'value': '65', 'spread': '7.071', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'Systolic and diastolic blood pressure was assessed before treatment, during treatment, and 15 minutes after the end of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Subjective Work of Breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minute 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Minute 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minute 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minute 30 (15 minutes post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'Participants were observed for stridor, grunting, nasal flaring, or accessory muscle use. The presence of any of these indicates that increased effort is required for breathing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on subjective work of breathing were not collected at the Baseline and Minute 30 time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants were enrolled at Emory Saint Joseph's Hospital and Emory University Hospital in Atlanta, Georgia. Enrollment began on April 8, 2020 and all follow up was complete by August 31, 2020."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.71', 'spread': '21.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-01', 'size': 643985, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-29T09:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2020-03-31', 'resultsFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-05', 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen Saturation by Pulse Oximetry', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'Pulse oximetry is a way to assess whether or not a patient needs help breathing. Oxygen saturation levels for healthy individuals are 95% and above.'}], 'secondaryOutcomes': [{'measure': 'Respiratory Rate', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'The number of breaths per minute was assessed before treatment, during treatment, and 15 minutes after the end of treatment.'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'Heart rate, in beats per minute, was assessed before treatment, during treatment, and 15 minutes after the end of treatment.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'Systolic and diastolic blood pressure was assessed before treatment, during treatment, and 15 minutes after the end of treatment.'}, {'measure': 'Count of Participants With Subjective Work of Breathing', 'timeFrame': 'Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)', 'description': 'Participants were observed for stridor, grunting, nasal flaring, or accessory muscle use. The presence of any of these indicates that increased effort is required for breathing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Bidirectional oxygenation', 'Pulmonary compromise', 'Supplemental oxygen'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the safety, feasibility and efficacy of a bidirectional oxygenation Positive End Expiratory Pressure (PEEP) mouthpiece in coronavirus disease 2019 (COVID-19) patients requiring supplemental oxygen by non-rebreather mask.', 'detailedDescription': 'Severe cases of COVID-19 often mimic the typical course of Adult Respiratory Distress Syndrome (ARDS) and its predictable sequelae. These patients often require intubation and ventilator support in order to sustain adequate oxygenation. Once a COVID-19 patient is intubated, Positive End Expiratory Pressure (PEEP) is a mainstay of treatment and is used in order to improve lung function, treat underlying atelectasis, improve oxygenation, and improve survival. In fact, early clinical data as well as reports from front line physicians treating COVID-19 suggest that PEEP has been the most effective treatment modality. In many cases, PEEP has resulted in improved oxygenation and improved survival.\n\nPEEP decreases the propensity for the alveoli to collapse by increasing the air pressure in the lungs. This residual pressure in the lungs at the end of exhalation decreases shunting and allows for more complete gas exchange and improved oxygenation. In patients, PEEP is one of the safest ways to increase partial pressure of oxygen (PaO2) and is used on almost all modern ventilator settings.\n\nThe GO2 PEEP MOUTHPIECE is a simple, comfortable, and straightforward mouthpiece with a bidirectional valve that effectively delivers PEEP with every breath. Early application of the GO2 PEEP MOUTHPIECE in non-intubated COVID-19 patients may improve outcomes and save lives. Furthermore, this device may allow for less strain on limited resources, especially ventilators. This PEEP mouthpiece could be employed under an oxygen non-rebreather mask to improve oxygenation and avoid intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 positive\n* Oxygen saturation \\<92%\n* Able to provide informed consent\n* Receiving oxygen by non-rebreather mask\n* Not currently requiring intubation\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent\n* Cognitive impairment\n* Rapidly decompensating status requiring urgent or emergent higher level of care'}, 'identificationModule': {'nctId': 'NCT04331366', 'acronym': 'GO2 PEEP', 'briefTitle': 'Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'GO2 PEEP Study: The Use of a Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19', 'orgStudyIdInfo': {'id': 'STUDY00000381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with GO2 PEEP MOUTHPIECE', 'description': 'Participants receiving treatment with the GO2 PEEP MOUTHPIECE', 'interventionNames': ['Device: GO2 PEEP MOUTHPIECE']}], 'interventions': [{'name': 'GO2 PEEP MOUTHPIECE', 'type': 'DEVICE', 'description': 'The GO2 PEEP MOUTHPIECE has a bidirectional valve that delivers PEEP with each breath. Participants will be provided a G02 PEEP MOUTHPIECE to use underneath the oxygen face mask and will be instructed to breathe slowly and deeply through the mouthpiece for 15 minutes total. Metrics for primary and secondary endpoints will be recorded immediately prior to use and then at 5, 10 and 15 minutes of use and then 15 minutes after cessation of use.', 'armGroupLabels': ['Treatment with GO2 PEEP MOUTHPIECE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory St. Joseph's Hospital", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Jeffrey Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jeffrey Miller', 'investigatorAffiliation': 'Emory University'}}}}