Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT04723433
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2021-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In the post-anesthesia care unit (PACU), participants will be randomized to receive conservative (titrated to an SpO2 between 90 and 94%) versus liberal (titrated to SpO2 \\> 96%) oxygen supplementation, via a non-rebreather mask.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-11', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcutaneous partial pressure of carbon dioxide (TcPCO2)', 'timeFrame': 'Ninety -minute period immediately post-anesthesia.', 'description': 'The cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide (TcPCO2: primary outcome) will exceed an upper limit of 45 mmHg (i.e., TcPCO2 \\> 45 mmHg)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilatory Depression', 'Postoperative Respiratory Complication']}, 'referencesModule': {'references': [{'pmid': '36265267', 'type': 'DERIVED', 'citation': 'Doufas AG, Tian L, Kutscher S, Finnsson E, Agustsson JS, Chung BI, Panousis P. The effect of hyperoxia on ventilation during recovery from general anesthesia: A randomized pilot study for a parallel randomized controlled trial. J Clin Anesth. 2022 Dec;83:110982. doi: 10.1016/j.jclinane.2022.110982. Epub 2022 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.', 'detailedDescription': 'The purpose of this study is characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period, since hyperoxemia (ie., higher than necessary partial pressure of oxygen in the arterial blood) has been associated with ventilatory depression via suppression of the hypoxic ventilatory drive.\n\nIn this feasibility randomized controlled trial, the investigators plan to estimate and compare the cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide will exceed an upper limit of 45 mmHg (i.e., TcPCO2 \\> 45 mmHg) for the 90-min-long post-anesthesia period, between the conventional (titrated to an oxygen saturation \\> 96%) and the conservative (titrated to O2 saturation 90 -94%) O2 supplementation interventions.\n\nHypothesis: Conservative use of O2 (titrated to an SpO2: 90 - 94%), will be associated with less hypoventilation (i.e., less time spent with an TcPCO2 \\> 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 \\> 96%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Body mass index (BMI) less than 40 kg/m2\n* Scheduled to undergo robotic-assisted radical laparoscopic nephrectomy.\n\nExclusion Criteria:\n\n* Patients with a diagnosis of chronic obstructive pulmonary disorder (COPD), severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder\n* Chronic pain condition that is being treated with opioids\n* Patients with a hematocrit lower than 30% at the end of surgery, or those with an excessive blood loss, requiring transfusion of blood products during their surgery, will be also excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04723433', 'briefTitle': 'Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Recovery of Ventilation After General Anesthesia for Robotic-assisted Laparoscopic Nephrectomy: The Effect of Conservative Versus Liberal Oxygen Supplementation - A Feasibility Study', 'orgStudyIdInfo': {'id': 'IRB-59593'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Conservative O2 Supplementation"', 'description': 'Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.', 'interventionNames': ['Other: Oxygen gas -Conservative']}, {'type': 'ACTIVE_COMPARATOR', 'label': '"Liberal O2 Supplementation"', 'description': 'Oxygen administration will titrated to an SpO2 \\> 96%.', 'interventionNames': ['Other: Oxygen gas -Liberal']}], 'interventions': [{'name': 'Oxygen gas -Conservative', 'type': 'OTHER', 'description': 'Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90% and 94%.', 'armGroupLabels': ['"Conservative O2 Supplementation"']}, {'name': 'Oxygen gas -Liberal', 'type': 'OTHER', 'description': 'Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) higher than 96%.', 'armGroupLabels': ['"Liberal O2 Supplementation"']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Anesthesiology, Perioperative and Pain Medicine', 'investigatorFullName': 'Anthony Doufas', 'investigatorAffiliation': 'Stanford University'}}}}