Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 7:37 AM
Study NCT ID:
NCT06249659
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2024-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Extubation Location After Surgery on Perioperative Times
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060666', 'term': 'Airway Extubation'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 756}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Additional operative room occupancy time associated with awakening and extubation', 'timeFrame': 'From end of procedure until extubation, assessed up to 2 hours', 'description': 'Time between dressing application (or end of procedure if there was no cutaneous effraction) and discharge from the OR'}], 'secondaryOutcomes': [{'measure': 'Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation', 'timeFrame': 'From end of procedure until extubation, assessed up to 2 hours', 'description': 'Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation'}, {'measure': 'Time from the end of anaesthesia drug administration to extubation', 'timeFrame': 'From end of anesthesia drug administration until extubation, assessed up to 2 hours', 'description': 'Time from the end of anaesthesia drug administration to extubation'}, {'measure': 'Time from the end of the surgical procedure to patient able to be transferred to the ward (as defined by an Aldrete score above 10)', 'timeFrame': 'From end of procedure until discharge to surgical ward, assessed up to 6 hours', 'description': "Time from the end of the surgical procedure to patient able to be transferred to the ward (as defined by an Aldrete score above or equal to 10). Aldrete's scoring system is a commonly used scale for determining when postsurgical patients can be safely discharged from the post-anesthesia care unit (PACU), generally to an hospital ward, or home. Modified Aldrete score ranges from 0 to 12."}, {'measure': 'Impact of sequencing of operating programme in the room concerned on extubation location', 'timeFrame': 'From end of procedure until next procedure in the same room, assessed up to one day', 'description': 'Impact of sequencing of operating programme in the room concerned on extubation location'}, {'measure': 'Incidence of oxygen support requirement_Day-1', 'timeFrame': 'First postoperative day', 'description': 'Oxygen support requirement on the first day post-extubation'}, {'measure': 'Reported post-operative pulmonary complications_Day7', 'timeFrame': 'Seven first postoperative days', 'description': 'Reported post-operative pulmonary complications within the first 7 days after extubation (as defined as acute respiratory failure, atelectasis, pneumonia, bronchospasm, pulmonary embolism or cardiorespiratory arrest)'}, {'measure': 'Oxygen therapy_PACU', 'timeFrame': 'From end of procedure until discharge to surgical ward, assessed up to 6 hours', 'description': 'Use of any rescue oxygen therapy after extubation in post-anesthesia care unit'}, {'measure': 'Hypotension_PACU', 'timeFrame': 'From end of procedure until discharge to surgical ward, assessed up to 6 hours', 'description': 'Hypotension occurrence (as defined by a systolic blood pressure below 90 mmHg and/or a mean arterial pressure below 65 mmHg)'}, {'measure': 'Bradycardia_PACU', 'timeFrame': 'From end of procedure until discharge to surgical ward, assessed up to 6 hours', 'description': 'Bradycardia occurrence (as defined as a drop of cardiac frequency below 50 beats.min-1)'}, {'measure': 'Hypoxemia_PACU', 'timeFrame': 'From end of procedure until discharge to surgical ward, assessed up to 6 hours', 'description': 'Desaturation occurrence defined as a drop of SpO2 below 96% (15), either early (within 5 min post-extubation) or delayed'}, {'measure': 'NMBA_PACU', 'timeFrame': 'From end of procedure until discharge to surgical ward, assessed up to 6 hours', 'description': 'Presence of residual neuromuscular blockade as illustrated by train of four below 90%'}, {'measure': 'Reversal_NMBA', 'timeFrame': 'From end of anesthesia until extubation, assessed up to 2 hours', 'description': 'Incidence of pharmacologic reversal of neuromuscular blocking agents'}, {'measure': 'Loco-regional anaesthetic technique', 'timeFrame': 'Perioperative', 'description': 'Use of any loco-regional anaesthetic technique'}, {'measure': 'Drugs_neuromuscular blocking agents', 'timeFrame': 'Perioperative', 'description': 'Use of neuromuscular blocking agents during anesthesia'}, {'measure': 'Drugs_opioids', 'timeFrame': 'Perioperative', 'description': 'Use of opioids during anesthesia'}, {'measure': 'Drugs_hypnotics', 'timeFrame': 'Perioperative', 'description': 'Use of hypnotics during anesthesia'}, {'measure': 'Drugs_adjuvant analgesics', 'timeFrame': 'Perioperative', 'description': 'Use of adjuvant analgesics during anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['General anesthesia', 'Extubation', 'Intubation', 'Time', 'Complications'], 'conditions': ['Anesthesia', 'Intubation', 'Surgery', 'Extubation', 'Respiratory Failure', 'Complication,Postoperative']}, 'descriptionModule': {'briefSummary': "The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates.", 'detailedDescription': "The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates. The primary objective was to evaluate the additional OR occupancy time associated with awakening and extubation. Secondary objectives were to assess the rate of post-extubation complications and the need for ventilatory support. This was a prospective multicenter observational study involving intubated patients who underwent surgeries in the operating theatres of the Montpellier and Clermont-Ferrand university hospitals. Anesthesia teams were asked to complete a form including data related to the patient, surgical procedure, anesthesia procedure (induction and recovery) and the occurrence of any complications during the procedure. A multivariate analysis was conducted on the full cohort, using a propensity score (IPTW, inverse probability of treatment weighting) to account for imbalances between groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient requiring endotracheal extubation after general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (older than 18 years old)\n* Patients admitted to any operative room of participating centre for a surgical or endoscopic procedure under general anaesthesia requiring endo-tracheal intubation\n* Subjects must be covered by public health insurance\n* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.\n\nExclusion Criteria:\n\n* Patient extubated in intensive care unit\n* Patient extubated during on-call hours (because of a reduced number of medical and paramedical staff)\n* Patient extubated following cardiac surgery\n* Refusal of study participation or to pursue the study by the patient\n* Absence of coverage by the French statutory healthcare insurance system\n* Protected person'}, 'identificationModule': {'nctId': 'NCT06249659', 'acronym': 'Extub_Loca', 'briefTitle': 'Impact of Extubation Location After Surgery on Perioperative Times', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Impact of Extubation Location After Surgery on Perioperative Times. A Prospective Multicenter Observational Study. Extub_Loca Study', 'orgStudyIdInfo': {'id': 'IRB-MTP_2022_04_202201100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extubation in operative room', 'description': 'Patients are extubated in operative room after the end of surgery', 'interventionNames': ['Procedure: Extubation in operative room']}, {'label': 'Extubation in post anesthesia care unit', 'description': 'Patients are extubated in post anesthesia care unit, after transfer from operative room', 'interventionNames': ['Procedure: Extubation in post anesthesia care unit']}], 'interventions': [{'name': 'Extubation in operative room', 'type': 'PROCEDURE', 'description': 'Extubation takes place in operative room', 'armGroupLabels': ['Extubation in operative room']}, {'name': 'Extubation in post anesthesia care unit', 'type': 'PROCEDURE', 'description': 'Extubation takes place in post anesthesia care unit', 'armGroupLabels': ['Extubation in post anesthesia care unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Clermont-Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Thomas Godet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clermont-Ferrand University Hospitals'}, {'name': 'Audrey De Jong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Available upon reasonable request after evaluation of research question'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Montpellier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}