Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04951960
Status:
UNKNOWN
Last Update Posted:
2021-07-15
First Post:
2020-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000097742', 'term': 'Patient-Ventilator Asynchrony'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, their legal representatives, and outcomes assessor are blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-11', 'studyFirstSubmitDate': '2020-11-01', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.', 'timeFrame': 'Through study completion (up to 24 hours)'}], 'secondaryOutcomes': [{'measure': 'Asynchrony index of each types of patient ventilator asynchrony at higher and lower PEEP.', 'timeFrame': 'Through study completion (up to 24 hours)'}, {'measure': 'The intensity of spontaneous breathing effort measured by esophageal manometry at higher and lower PEEP', 'timeFrame': 'Through study completion (up to 24 hours)'}, {'measure': 'Minute volume at higher and lower PEEP', 'timeFrame': 'Through study completion (up to 24 hours)'}, {'measure': 'The efficiency of diaphragmatic contraction measured by electrical activity of diaphragm at higher and lower PEEP.', 'timeFrame': 'Through study completion (up to 24 hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient ventilator asynchrony', 'positive end expiratory pressure'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': "Patient-ventilator asynchrony is known to frequently occur during lung protective ventilation in patients with ARDS. Previous clinical studies showed that patient-ventilator asynchrony was associated with worse outcome in ICU. Therefore, strategies to reduce patient-ventilator asynchrony need to be established promptly. Several asynchronies, e.g., breath stacking are caused by vigorous spontaneous breathing effort. Recently, the investigators' group found that higher positive end expiratory pressure (PEEP) reduced the intensity of spontaneous breathing effort of in severe ARDS model (rabbits, pigs) and patients with ARDS. Thus, the investigators conjectured that higher PEEP may reduce the intensity of spontaneous breathing effort and thereby reduce patient-ventilator asynchrony during protective ventilation strategy, compared with lower PEEP in patients with ARDS.", 'detailedDescription': 'The cross-over study will enroll 10 participants fulfilled with the criteria of Berlin definition of moderate-to-severe ARDS and under mechanical ventilation in intensive care unit (ICU) at Osaka University Hospital. Informed consent will be obtained by legal representatives. After obtaining informed consent, participants will be randomly assigned to one of two groups: "higher PEEP - lower PEEP" or "lower PEEP - higher PEEP". PEEP, either higher or lower, will be set according to higher or lower PEEP/FIO2 table. The depth of sedation will be monitored quantitively and maintained to be the same throughout the protocol. The intensity of spontaneous breathing activity will be assessed with esophageal balloon manometry and electrical activity of diaphragm. At each PEEP setting, asynchrony index will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≧ 18 years old\n2. Patients with moderate to severe ARDS under mechanical ventilation＊ ＊ Definition of moderate to severe ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 200 mmHg with PEEP ≧ 5 cmH2O)\n\nExclusion Criteria:\n\n1. Lack of informed consent\n2. Continuous neuromuscular blockade at enrollment\n3. DNR (do-not-resuscitate)\n4. Moribund patient not expected to survive 24 hours\n5. Massive hemoptysis\n6. Increased intracranial pressure (\\> 18 mmHg)\n7. Existence or high risk of pneumothorax\n8. Known pregnancy\n9. Actual body weight exceeding 1 kg/cm\n10. Patient judged to be inappropriate for the trial by intensivist'}, 'identificationModule': {'nctId': 'NCT04951960', 'briefTitle': 'The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony', 'organization': {'class': 'OTHER', 'fullName': 'Osaka University'}, 'officialTitle': 'The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony in Patients With Acute Respiratory Distress Syndrome: a Cross-Over Randomized Trial', 'orgStudyIdInfo': {'id': 'PEEPPVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A group from higher PEEP to lower PEEP', 'description': 'Patient allocated for this arm are received from higher to lower PEEP setting.', 'interventionNames': ['Other: Higher PEEP setting', 'Other: Lower PEEP setting']}, {'type': 'OTHER', 'label': 'A group from lower PEEP to higher PEEP', 'description': 'Patient allocated for this arm are received from lower to higher PEEP setting.', 'interventionNames': ['Other: Higher PEEP setting', 'Other: Lower PEEP setting']}], 'interventions': [{'name': 'Higher PEEP setting', 'type': 'OTHER', 'description': 'PEEP levels are determined according to the higher PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour.', 'armGroupLabels': ['A group from higher PEEP to lower PEEP', 'A group from lower PEEP to higher PEEP']}, {'name': 'Lower PEEP setting', 'type': 'OTHER', 'description': 'PEEP levels are determined according to the lower PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour.', 'armGroupLabels': ['A group from higher PEEP to lower PEEP', 'A group from lower PEEP to higher PEEP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suita', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takeshi Yoshida, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'takeshiyoshida@hp-icu.med.osaka-u.ac.jp', 'phone': '+81668795820'}], 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'centralContacts': [{'name': 'Takeshi Yoshida, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'takeshiyoshida@hp-icu.med.osaka-u.ac.jp', 'phone': '+81668795820'}], 'overallOfficials': [{'name': 'Takeshi Yoshida, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osaka University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osaka University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}