Impact of Extubation Location After Surgery on Perioperative Times

Completed

• Conditions: Respiratory Failure; Extubation; Complication,Postoperative; Surgery; Anesthesia; Intubation
• Interventions: Procedure: Extubation in post anesthesia care unit; Procedure: Extubation in operative room

• Registration Number: NCT06249659
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2023-01-28
• Study Completion: 2023-02-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

Inclusion Criteria

• Adult (older than 18 years old)
• Patients admitted to any operative room of participating centre for a surgical or endoscopic procedure under general anaesthesia requiring endo-tracheal intubation
• Subjects must be covered by public health insurance
• 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.

Exclusion Criteria

• Patient extubated in intensive care unit
• Patient extubated during on-call hours (because of a reduced number of medical and paramedical staff)
• Patient extubated following cardiac surgery
• Refusal of study participation or to pursue the study by the patient
• Absence of coverage by the French statutory healthcare insurance system
• Protected person

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extubation in post anesthesia care unit	Extubation in post anesthesia care unit	Patients are extubated in post anesthesia care unit, after transfer from operative room
Extubation in operative room	Extubation in operative room	Patients are extubated in operative room after the end of surgery

Primary Outcome Measures

Name	Time	Method
Additional operative room occupancy time associated with awakening and extubation	From end of procedure until extubation, assessed up to 2 hours	Time between dressing application (or end of procedure if there was no cutaneous effraction) and discharge from the OR

Secondary Outcome Measures

Name	Time	Method
Reported post-operative pulmonary complications_Day7	Seven first postoperative days	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)
Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation	From end of procedure until extubation, assessed up to 2 hours	Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation
Time from the end of anaesthesia drug administration to extubation	From end of anesthesia drug administration until extubation, assessed up to 2 hours	Time from the end of anaesthesia drug administration to extubation
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)	From end of procedure until discharge to surgical ward, assessed up to 6 hours	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.
Impact of sequencing of operating programme in the room concerned on extubation location	From end of procedure until next procedure in the same room, assessed up to one day	Impact of sequencing of operating programme in the room concerned on extubation location
Incidence of oxygen support requirement_Day-1	First postoperative day	Oxygen support requirement on the first day post-extubation
Oxygen therapy_PACU	From end of procedure until discharge to surgical ward, assessed up to 6 hours	Use of any rescue oxygen therapy after extubation in post-anesthesia care unit
Bradycardia_PACU	From end of procedure until discharge to surgical ward, assessed up to 6 hours	Bradycardia occurrence (as defined as a drop of cardiac frequency below 50 beats.min-1)
Reversal_NMBA	From end of anesthesia until extubation, assessed up to 2 hours	Incidence of pharmacologic reversal of neuromuscular blocking agents
Hypotension_PACU	From end of procedure until discharge to surgical ward, assessed up to 6 hours	Hypotension occurrence (as defined by a systolic blood pressure below 90 mmHg and/or a mean arterial pressure below 65 mmHg)
Drugs_opioids	Perioperative	Use of opioids during anesthesia
Hypoxemia_PACU	From end of procedure until discharge to surgical ward, assessed up to 6 hours	Desaturation occurrence defined as a drop of SpO2 below 96% (15), either early (within 5 min post-extubation) or delayed
NMBA_PACU	From end of procedure until discharge to surgical ward, assessed up to 6 hours	Presence of residual neuromuscular blockade as illustrated by train of four below 90%
Loco-regional anaesthetic technique	Perioperative	Use of any loco-regional anaesthetic technique
Drugs_neuromuscular blocking agents	Perioperative	Use of neuromuscular blocking agents during anesthesia
Drugs_hypnotics	Perioperative	Use of hypnotics during anesthesia
Drugs_adjuvant analgesics	Perioperative	Use of adjuvant analgesics during anesthesia

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France