Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-04 @ 2:50 PM
Study NCT ID:
NCT02966535
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2016-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2016-11-13', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "PaCO2 (mmHg) in the patient's arterial blood gas analysis", 'timeFrame': '60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning', 'description': 'PaCO2 (arterial partial pressure of carbon dioxide)'}], 'secondaryOutcomes': [{'measure': "PaCO2 (mmHg) in the patient's arterial blood gas analysis", 'timeFrame': '5 minutes after anesthesia induction', 'description': 'PaCO2 (arterial partial pressure of carbon dioxide)'}, {'measure': "PaO2 (mmHg) in the patient's arterial blood gas analysis", 'timeFrame': '5 minutes after anesthesia induction', 'description': 'PaO2 (arterial partial pressure of oxygen)'}, {'measure': "PaO2 (mmHg) in the patient's arterial blood gas analysis", 'timeFrame': '60 minutes after anesthesia induction', 'description': 'PaO2 (arterial partial pressure of oxygen)'}, {'measure': "PaCO2 (mmHg) in the patient's arterial blood gas analysis", 'timeFrame': '120 minutes after anesthesia induction', 'description': 'PaCO2 (arterial partial pressure of carbon dioxide)'}, {'measure': "PaO2 (mmHg) in the patient's arterial blood gas analysis", 'timeFrame': '120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning', 'description': 'PaO2 (arterial partial pressure of oxygen)'}, {'measure': "PaCO2 (mmHg) in the patient's arterial blood gas analysis", 'timeFrame': '10 min after restoration of supine position', 'description': 'PaCO2 (arterial partial pressure of carbon dioxide)'}, {'measure': "PaO2 (mmHg) in the patient's arterial blood gas analysis", 'timeFrame': '10 min after restoration of supine position', 'description': 'PaO2 (arterial partial pressure of oxygen)'}, {'measure': 'Respiratory compliance (Static, Dynamic)', 'timeFrame': '5 minutes after anesthesia induction', 'description': 'Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)'}, {'measure': 'Respiratory compliance (Static, Dynamic)', 'timeFrame': '60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning', 'description': 'Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)'}, {'measure': 'Respiratory compliance (Static, Dynamic)', 'timeFrame': '120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning', 'description': 'Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)'}, {'measure': 'oxygen index', 'timeFrame': '5 minutes after anesthesia induction', 'description': 'oxygen index calculated by PaO2/inspired oxygen fraction'}, {'measure': 'oxygen index', 'timeFrame': '60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning', 'description': 'oxygen index calculated by PaO2/inspired oxygen fraction'}, {'measure': 'oxygen index', 'timeFrame': '120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning', 'description': 'oxygen index calculated by PaO2/inspired oxygen fraction'}, {'measure': 'Alveolar-arterial oxygen difference', 'timeFrame': '5 minutes after anesthesia induction'}, {'measure': 'Alveolar-arterial oxygen difference', 'timeFrame': '60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning'}, {'measure': 'Alveolar-arterial oxygen difference', 'timeFrame': '120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasm', 'Urinary Bladder Neoplasm']}, 'referencesModule': {'references': [{'pmid': '25277444', 'type': 'BACKGROUND', 'citation': 'De Carlo F, Celestino F, Verri C, Masedu F, Liberati E, Di Stasi SM. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: surgical, oncological, and functional outcomes: a systematic review. Urol Int. 2014;93(4):373-83. doi: 10.1159/000366008. Epub 2014 Sep 23.'}, {'pmid': '22415437', 'type': 'BACKGROUND', 'citation': 'Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.'}, {'pmid': '25869025', 'type': 'BACKGROUND', 'citation': 'Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic surgery.', 'detailedDescription': 'Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic surgery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status class I-II and scheduled for an elective robot-assisted laparoscopic radical prostatectomy or robot-assisted laparoscopic radical cystectomy\n* Patients who voluntarily decides to participate in the trial and has agreed in written informed consent\n\nExclusion Criteria:\n\n* Patients with the anatomical abnormalities of respiratory system(abnormal airway anatomy, severe scoliosis, post-pneumonectomy state), severe chronic respiratory diseases, chronic obstructive pulmonary disease (COPD), asthma, heart failure, obesity ( Body Mass Index \\[BMI\\] \\> 30kg/m2), severe hepatic failure or renal failure'}, 'identificationModule': {'nctId': 'NCT02966535', 'briefTitle': 'The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '1609-102-793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1:2, 1:1 group', 'description': 'Inspiratory to expiratory time ratio (I:E ratio) of 1:2 during the first one hour of laparoscopy and then switched to I:E ratio of 1:1 during the rest time of laparoscopy.', 'interventionNames': ['Device: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1:1, 1:2 group', 'description': 'Inspiratory to expiratory time ratio (I:E ratio) of 1:1 during the first one hour of laparoscopy and then switched to I:E ratio of 1:2 during the rest time of laparoscopy.', 'interventionNames': ['Device: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)']}], 'interventions': [{'name': 'Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)', 'type': 'DEVICE', 'description': 'Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)', 'armGroupLabels': ['1:2, 1:1 group']}, {'name': 'Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)', 'type': 'DEVICE', 'description': 'Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)', 'armGroupLabels': ['1:1, 1:2 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Won Ho Kim, MD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}