Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT03511651
Status:
UNKNOWN
Last Update Posted:
2020-05-29
First Post:
2018-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2018-04-08', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of FRC', 'timeFrame': '1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O', 'description': 'EELV measurement by ICU ventilator; PEEP Volume measured through airway release. FRC will be calculated as EELV minus PEEP volume. Correlation between EELV, PEEP volume, FRC at two different PEEP levels are tested by linear regression analysis.'}], 'secondaryOutcomes': [{'measure': 'The change of PaO2/FiO2 Ratio', 'timeFrame': '1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O', 'description': 'Obtaining PaO2 according to blood gas analysis, and FiO2 according to the ventilator'}, {'measure': 'The change of regional EELV', 'timeFrame': '1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O', 'description': 'Regional EELV will be measured at clinical PEEP and clinical PEEP +5cmH2O'}, {'measure': 'The change of homogeneity of distribution of tidal volume', 'timeFrame': '1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O', 'description': 'EIT is used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area. The ratio of relative distribution of tidal ventilation of two ROI was calculated.'}, {'measure': 'The change of driving Pressure', 'timeFrame': '1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O', 'description': 'The change of driving pressure will be measured.'}, {'measure': 'The change of regional FRC', 'timeFrame': '1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O', 'description': 'Regional FRC will be measured at clinical PEEP and clinical PEEP +5cmH2O'}, {'measure': 'The change of blood pressure', 'timeFrame': '1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O', 'description': 'The change of blood pressure will be measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation', 'Acute Respiratory Distress Syndrome', 'Functional Residual Capacity']}, 'descriptionModule': {'briefSummary': 'Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP. Whether the FRC changes at different PEEP levels remains unknown.', 'detailedDescription': 'Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP.\n\nPassive spirometry has long been used to measure the lung recruitment volume (VREC). A prolonged expiration to zero end-expiratory pressure (ZEEP) or airway release maneuver is required and PEEP induced lung volume change above functional residual capacity (FRC) is measured. This technique assumes that FRC does not change at different PEEP levels.\n\nThis assumption that PEEP has no effect on FRC can date back to the study of Valta et al in the early 1990s. Using respiratory inductive plethysmography (RIP), they found that in ALI/ARDS patients, after expiring from different PEEP levels to ZEEP, the plethysmography signal returned to the same baseline value. They concluded that FRC does not change with PEEP, and that changes of EELV are attributable only to change in ∆EELV. Ranieri et al arrived at similar conclusions by measuring differences in lung volumes at different PEEP levels using standardized pressure-volume (P-V) curves derived from the ventilator circuit monitors. However, Patroniti et al found an elevation of FRC as increasing of PEEP in patients with ARDS. In this study, FRC was measured with the helium dilution technique, and concluded that neglecting this effect resulted in marked underestimation of VREC. Whether the FRC changes at different PEEP levels remains controversial. The aim of the study is to assess the effect of PEEP on FRC during mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria include:\n\n1. Diagnosed with ARDS according to the Berlin Definition;\n2. Age 18-80 years;\n3. Ventilated with volume-controlled ventilation using constant flow;\n4. Deep sedation (RASS -4 to -5) and absence of spontaneous breathing (i.e., no triggering during tidal breaths and no inspiratory effort during a 5-second end-expiratory hold).\n\nExclusion criteria include:\n\n1. Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube;\n2. Chest wall and/or abdominal injuries;\n3. Evidence suggesting reduced chest wall compliance, such as existing large pleural effusion, thoracic trauma and intra-abdominal hypertension (i.e., intra-abdominal pressure \\> 20 mmHg).\n4. Presence of pacemaker, defibrillator, and implantable pumps).'}, 'identificationModule': {'nctId': 'NCT03511651', 'briefTitle': 'The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'KY2018-004-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FRC at clinical PEEP level', 'description': 'Measuring FRC at clinical PEEP level', 'interventionNames': ['Procedure: PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'FRC at clinical PEEP + 5cmH2O', 'description': 'Increasing PEEP to clinical PEEP + 5cmH2O', 'interventionNames': ['Procedure: PEEP']}], 'interventions': [{'name': 'PEEP', 'type': 'PROCEDURE', 'description': 'Two PEEP levels will be used during mechanical ventilation.', 'armGroupLabels': ['FRC at clinical PEEP + 5cmH2O', 'FRC at clinical PEEP level']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Jian-Xin Zhou, MD', 'role': 'CONTACT', 'email': 'zhoujx.cn@icloud.com', 'phone': '8610 67096579'}], 'facility': 'Jian-Xin Zhou', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jian-Xin Zhou, MD', 'role': 'CONTACT', 'email': 'zhoujx.cn@icloud.com', 'phone': '8610 67096579'}], 'overallOfficials': [{'name': 'Jian-Xin Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian-Xin Zhou', 'investigatorAffiliation': 'Capital Medical University'}}}}