Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06044402
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, double-blind, controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PaO2/FiO2', 'timeFrame': 'the lowest value at one hour after extubation, day-1 to day-3', 'description': 'the outcome in mmHg'}, {'measure': 'hypoxemia', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'pneumonia', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'bronchospasm', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'atelectasis', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'pulmonary congestion', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'respiratory failure', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'pleural effusion', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'pneumothorax', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'unplanned requirement for postoperative invasive or noninvasive ventilation', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}], 'secondaryOutcomes': [{'measure': 'Tidal volume', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in milliliter'}, {'measure': 'respiratory rate', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in times/minute (frequency)'}, {'measure': 'dead space fraction', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in fraction'}, {'measure': 'A-aDO2', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in mmHg'}, {'measure': 'intrapulmonary shunt', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in fraction'}, {'measure': 'peak airway pressure', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in cmH2O'}, {'measure': 'plateau airway pressure', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in cmH2O'}, {'measure': 'mean airway pressure', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in cmH2O'}, {'measure': 'dynamic compliance', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)', 'description': 'the outcome in milliliter/cmH2O'}, {'measure': 'arterial blood pH', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in number'}, {'measure': 'arterial blood PO2', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmHg'}, {'measure': 'arterial blood PCO2', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmHg'}, {'measure': 'arterial blood Hb', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in g/dl'}, {'measure': 'arterial blood Hct', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in fraction'}, {'measure': 'arterial blood SO2', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in fraction'}, {'measure': 'arterial blood K', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmol/L'}, {'measure': 'arterial blood Na', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmol/L'}, {'measure': 'arterial blood Ca', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmol/L'}, {'measure': 'arterial blood Cl', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmol/L'}, {'measure': 'arterial blood Glu', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmol/L'}, {'measure': 'arterial blood Lac', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmol/L'}, {'measure': 'arterial blood tBil', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in umol/L'}, {'measure': 'arterial blood SBE', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmol/L'}, {'measure': 'arterial blood ABE', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmol/L'}, {'measure': 'PaO2/FiO2', 'timeFrame': 'before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).', 'description': 'the outcome in mmHg'}, {'measure': 'unplanned intensive care unit admission', 'timeFrame': 'From date of finishing surgery until the date of patient discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'intensive care unit length of stay', 'timeFrame': 'From date of finishing surgery until the date of patient discharge, assessed up to 7 days', 'description': 'the outcome in days'}, {'measure': 'postoperative mortality', 'timeFrame': 'From date of finishing surgery until the date of patient discharge, assessed up to 7 days', 'description': 'the outcome in fraction'}, {'measure': 'hospital length of stay', 'timeFrame': 'From date of patient admission until the date of discharge, assessed up to 10 days', 'description': 'the outcome in days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trendelenburg', 'Neumoperitoneum', 'Oxygenation', 'Respiratory', 'Pulmonary']}, 'descriptionModule': {'briefSummary': 'The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-III class;\n* Colorectal cancer patients;\n* Elective laparoscopic colorectal surgery;\n* expected duration of surgery greater than 2 hours.\n\nExclusion Criteria:\n\n* serious complications associated with other systems;\n* severe cardiac insufficiency;\n* renal failure;\n* body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2;\n* the use of low tidal volume and consequent hypercapnia can induce harm;\n* refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06044402', 'briefTitle': 'Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Gansu Provincial Hospital'}, 'officialTitle': 'Effect of Intraoperative Low Tidal Volume vs Intermediate Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'GanSu Province Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group L', 'description': 'Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 6 ml/kg.', 'interventionNames': ['Other: group L (Vt 6 ml/kg)']}, {'type': 'EXPERIMENTAL', 'label': 'group I', 'description': 'Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 8 ml/kg.', 'interventionNames': ['Other: group I (Vt 8 ml/kg)']}], 'interventions': [{'name': 'group L (Vt 6 ml/kg)', 'type': 'OTHER', 'description': 'low tidal volume ventilation (tidal volume was set to 6 ml/kg)', 'armGroupLabels': ['group L']}, {'name': 'group I (Vt 8 ml/kg)', 'type': 'OTHER', 'description': 'intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)', 'armGroupLabels': ['group I']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'dong zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'dong zhang', 'investigatorAffiliation': 'Gansu Provincial Hospital'}}}}