Impact of Extubation Location After Surgery on Perioperative Times (Extub_Loca)

Impact of Extubation Location After Surgery on Perioperative Times. A Prospective Multicenter Observational Study. Extub_Loca Study

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Surgery; Intubation; Anesthesia; Complication,Postoperative; Extubation
• Intervention / Treatment: Procedure: Extubation in operative room; Procedure: Extubation in post anesthesia care unit

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 Type: Observational
• Enrollment (Actual): 756

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Clermont-Ferrand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient requiring endotracheal extubation after general anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Extubation in operative room; Patients are extubated in operative room after the end of surgery	Procedure: Extubation in operative room; Extubation takes place in operative room
Extubation in post anesthesia care unit; Patients are extubated in post anesthesia care unit, after transfer from operative room	Procedure: Extubation in post anesthesia care unit; Extubation takes place in post anesthesia care unit

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation	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 anaesthesia drug administration 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 the surgical procedure to patient able to be transferred to the ward (as defined by an Aldrete score above 10)	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.	From end of procedure until discharge to surgical ward, assessed up to 6 hours
Impact of sequencing of operating programme in the room concerned on extubation location	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
Incidence of oxygen support requirement_Day-1	Oxygen support requirement on the first day post-extubation	First postoperative day
Reported post-operative pulmonary complications_Day7	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)	Seven first postoperative days
Oxygen therapy_PACU	Use of any rescue oxygen therapy after extubation in post-anesthesia care unit	From end of procedure until discharge to surgical ward, assessed up to 6 hours
Hypotension_PACU	Hypotension occurrence (as defined by a systolic blood pressure below 90 mmHg and/or a mean arterial pressure below 65 mmHg)	From end of procedure until discharge to surgical ward, assessed up to 6 hours
Bradycardia_PACU	Bradycardia occurrence (as defined as a drop of cardiac frequency below 50 beats.min-1)	From end of procedure until discharge to surgical ward, assessed up to 6 hours
Hypoxemia_PACU	Desaturation occurrence defined as a drop of SpO2 below 96% (15), either early (within 5 min post-extubation) or delayed	From end of procedure until discharge to surgical ward, assessed up to 6 hours
NMBA_PACU	Presence of residual neuromuscular blockade as illustrated by train of four below 90%	From end of procedure until discharge to surgical ward, assessed up to 6 hours
Reversal_NMBA	Incidence of pharmacologic reversal of neuromuscular blocking agents	From end of anesthesia until extubation, assessed up to 2 hours
Loco-regional anaesthetic technique	Use of any loco-regional anaesthetic technique	Perioperative
Drugs_neuromuscular blocking agents	Use of neuromuscular blocking agents during anesthesia	Perioperative
Drugs_opioids	Use of opioids during anesthesia	Perioperative
Drugs_hypnotics	Use of hypnotics during anesthesia	Perioperative
Drugs_adjuvant analgesics	Use of adjuvant analgesics during anesthesia	Perioperative

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Hospital, Montpellier
• Investigators: Principal Investigator: Thomas Godet, MD, PhD, Clermont-Ferrand University Hospitals; Principal Investigator: Audrey De Jong, MD, PhD, Montpellier University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): January 28, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Complications; Intubation; Time; Extubation; General anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: IRB-MTP_2022_04_202201100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Available upon reasonable request after evaluation of research question

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No