Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-01-25 @ 2:21 AM
Study NCT ID:
NCT02105220
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}], 'ancestors': [{'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': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End Expiratory Lung Volumes', 'timeFrame': '2 hours', 'description': 'EELV variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension'}], 'secondaryOutcomes': [{'measure': 'Respiratory mechanics', 'timeFrame': '24 hours', 'description': 'Evaluation of effects of PEEP level set by ICU staff on respiratory mechanics after 24 hours from enrollment Evaluation of PEEP level set by ICU staff'}, {'measure': 'Work of breathing', 'timeFrame': '20 minutes', 'description': 'Evaluation of work of breathing variation at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients'}, {'measure': 'Respiratory mechanics', 'timeFrame': '2 hours', 'description': 'Respiratory mechanics variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension'}, {'measure': 'Gas Exchange', 'timeFrame': '2 hours', 'description': 'Gas exchange variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension'}, {'measure': 'Respiratory mechanics', 'timeFrame': '20 minutes', 'description': 'Evaluation of respiratory mechanics at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients'}, {'measure': 'Gas exchange', 'timeFrame': '20 minutes', 'description': 'Evaluation of gas exchange variation at different level of PEEP during spontaneous breathing and ventilation weaning in morbidly obese patients'}, {'measure': 'End Expiratory Lung Volume', 'timeFrame': '24 hours', 'description': 'Evaluation of effects of PEEP level set by ICU staff on EELV after 24 hours from enrollment'}, {'measure': 'Gas Exchange', 'timeFrame': '24 hours', 'description': 'Evaluation of effects of PEEP level set by ICU staff on gas exchange after 24 hours from enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory mechanics', 'Esophageal pressure', 'Functional residual capacity', 'positive end-expiratory pressure'], 'conditions': ['Obesity', 'Intra-Abdominal Hypertension']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure.\n\nThe effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.\n\nPatients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.', 'detailedDescription': 'The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics. Investigators want to describe how extreme obesity and Intra-Abdominal Hypertension (IAH) affect normal respiratory system behavior. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.\n\nInvestigators will record and compare lung volumes, airway and transpulmonary pressure, gas exchange and hemodynamic changes caused by variations of PEEP. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Patients will then again be evaluated during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.\n\nInvestigators believe that assessment of the transpulmonary pressure and lung volumes is essential to correctly evaluate respiratory system function in patients in which the relationship between the lung and chest wall is altered. Improper mechanical ventilation leads to lung damage. High ventilatory volume/pressure are associated with lung overdistension, while low volume/pressure leads to lung collapse and cyclic opening and closing of alveoli. All of these mechanisms have been associated with ventilator induced lung injury and poorer outcomes. Adequate PEEP and transpulmonary pressure are fundamental in preventing this vicious cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We will enroll morbidly obese intubated patients and/or patients affected by intraabdominal hypertension admitted to medical ICUs and surgical ICUs at Massachusetts General Hospital. Patients with contraindication to esophageal balloon placement or with severe respiratory failure will be excluded from the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Requiring intubation and mechanical ventilation\n* BMI≥40 kg/m2 or IAP≥12 mmHg\n\nExclusion Criteria:\n\n* Known presence esophageal varices\n* Recent esophageal trauma or surgery\n* Severe thrombocytopenia (PTL≤10,000/mm3)\n* Severe coagulopathy (INR≥2)\n* Presence of pneumothorax\n* Pregnancy\n* Patients with diagnosed moderate to severe ARDS or with poor oxygenation index (PaO2/FiO2 \\< 200 mmHg)'}, 'identificationModule': {'nctId': 'NCT02105220', 'briefTitle': 'Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients', 'orgStudyIdInfo': {'id': '2013P001413'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese', 'description': 'We will enroll patients with BMI≥40 kg/m2 to describe the impact of obesity on chest wall compliance and respiratory mechanics.\n\nRespiratory mechanics assessment: We will assess respiratory mechanics through different end expiratory pressure settings and recording airway and esophageal pressure tracings.', 'interventionNames': ['Other: Respiratory mechanics assessment']}, {'label': 'Intraabdominal Hypertension', 'description': 'We will enroll patients with IAP≥12 mmHg to describe the impact of intraabdominal hypertension on chest wall compliance and respiratory mechanics.\n\nRespiratory mechanics assessment: We will assess respiratory mechanics through different end expiratory pressure settings and recording airway and esophageal pressure tracings.', 'interventionNames': ['Other: Respiratory mechanics assessment']}], 'interventions': [{'name': 'Respiratory mechanics assessment', 'type': 'OTHER', 'description': 'Data collection on respiratory mechanics, end expiratory lung volumes, gas exchanges, work of breathing. Data will be obtained by setting different end expiratory pressures and recording esophageal and airways pressure tracings.', 'armGroupLabels': ['Intraabdominal Hypertension', 'Obese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Robert M Kacmarek, PhD RRT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD RRT', 'investigatorFullName': 'Robert M. Kacmarek', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}