Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04633720
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2020-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance Volume Profile in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D013990', 'term': 'Tidal Volume'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D007320', 'term': 'Inspiratory Capacity'}, {'id': 'D014797', 'term': 'Vital Capacity'}, {'id': 'D014109', 'term': 'Total Lung Capacity'}, {'id': 'D008176', 'term': 'Lung Volume Measurements'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2020-11-08', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intratidal compliance profiles in each ventilator settings', 'timeFrame': 'During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)', 'description': 'The investigators will determine Intratidal compliance profile using the changes in compliance over time\n\n--\\> I, merely increasing compliance profile; IH, increasing turning into horizontal compliance profile; D, merely decreasing compliance profile; HD, horizontal turning into decreasing compliance profile; IHD, increasing turning into horizontal and further turning into decreasing compliance profile If compliance profile is I, the PEEP is low. On the other hand, compliance profile is D, PEEP level is considered to be high.'}], 'secondaryOutcomes': [{'measure': 'Respiratory compliance', 'timeFrame': 'During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)', 'description': 'ml cmH2O-1'}, {'measure': 'Driving pressure', 'timeFrame': 'During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)', 'description': 'cmH2O'}, {'measure': 'Blood pressure', 'timeFrame': 'During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)', 'description': 'mmHg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Compliance']}, 'referencesModule': {'references': [{'pmid': '34686309', 'type': 'DERIVED', 'citation': 'Lee JH, Kang P, Song IS, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Determining optimal positive end-expiratory pressure and tidal volume in children by intratidal compliance: a prospective observational study. Br J Anaesth. 2022 Jan;128(1):214-221. doi: 10.1016/j.bja.2021.09.024. Epub 2021 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'In children under 6 years of age undergoing regular surgery during general anesthesia, the intratidal compliance profile is evaluated when different tidal volumes are applied at different positive end expiratory pressures.\n\nThen determine the most appropriate combination of positive end-tidal pressure and tidal volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children undergoing surgery \\> 1 hour under general anesthesia\n* Children ≤ 6 years\n* American society of anesthesiology physical status I, II\n\nExclusion Criteria:\n\n* Previous lung surgery\n* Bronchopulmonary dysplasia, respiratory distress syndrome\n* Other interstitial lung disease\n* Laparoscopic surgery\n* Thoracic surgery, abdominal surgery'}, 'identificationModule': {'nctId': 'NCT04633720', 'briefTitle': 'Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance Volume Profile in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance-volume Profile in Children', 'orgStudyIdInfo': {'id': 'H2009-175-1162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluation of intratidal compliance', 'description': 'When the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order.\n\n1. Positive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg\n2. Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg\n3. Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg\n4. Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg', 'interventionNames': ['Other: Changes in positive end-expiratory pressure and tidal volume']}], 'interventions': [{'name': 'Changes in positive end-expiratory pressure and tidal volume', 'type': 'OTHER', 'description': 'When the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order.\n\nPositive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg', 'armGroupLabels': ['Evaluation of intratidal compliance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}