Impact of Extubation Location After Surgery on Perioperative Times

NCT06249659 | Completed

• 1 other identifier: IRB-MTP_2022_04_202201100
• Study Type: observational
• Target: 756
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Intubation; Surgery; Extubation; Respiratory Failure; Complication,Postoperative

Keywords

General anesthesia; Extubation; Intubation; Time; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

  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)

  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

  From end of procedure until next procedure in the same room, assessed up to one day

• Incidence of oxygen support requirement_Day-1

  First postoperative day

Study Arms (2)

Extubation in operative room

Patients are extubated in operative room after the end of surgery

Procedure: Extubation 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

Interventions

Extubation in operative room PROCEDURE

Extubation takes place in operative room

Extubation in operative room

Extubation in post anesthesia care unit PROCEDURE

Extubation takes place in post anesthesia care unit

Extubation in post anesthesia care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient requiring endotracheal extubation after general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• University Hospital, Montpellier: collaborator

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Postoperative Complications

Interventions

Airway Extubation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques

Study Officials

• Thomas Godet, MD, PhD

  Clermont-Ferrand University Hospitals

  PRINCIPAL INVESTIGATOR

• Audrey De Jong, MD, PhD

  Montpellier University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 8, 2024
• Study Start: September 1, 2020
• Primary Completion: January 28, 2023
• Study Completion: February 1, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

FR (1)