Skip to main content
OpenTrials
Completed

NCT Number: NCT06249659

Impact of Extubation Location After Surgery on Perioperative Times

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Complication,Postoperative Extubation Intubation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63000, France

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extubation in operative room

Procedure

Extubation takes place in operative room

Extubation in post anesthesia care unit

Procedure

Extubation takes place in post anesthesia care unit

Primary outcomes

  1. Additional operative room occupancy time associated with awakening and extubation

    Time frame: 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 outcomes

  1. Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation

    Time frame: 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

  2. Time from the end of anaesthesia drug administration to extubation

    Time frame: From end of anesthesia drug administration until extubation, assessed up to 2 hours

    Time from the end of anaesthesia drug administration to extubation

  3. 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 frame: 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.

  4. Impact of sequencing of operating programme in the room concerned on extubation location

    Time frame: 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

  5. Incidence of oxygen support requirement_Day-1

    Time frame: First postoperative day

    Oxygen support requirement on the first day post-extubation

  6. Reported post-operative pulmonary complications_Day7

    Time frame: 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)

  7. Oxygen therapy_PACU

    Time frame: 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

  8. Hypotension_PACU

    Time frame: 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)

  9. Bradycardia_PACU

    Time frame: 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)

  10. Hypoxemia_PACU

    Time frame: 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

  11. NMBA_PACU

    Time frame: 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%

  12. Reversal_NMBA

    Time frame: From end of anesthesia until extubation, assessed up to 2 hours

    Incidence of pharmacologic reversal of neuromuscular blocking agents

  13. Loco-regional anaesthetic technique

    Time frame: Perioperative

    Use of any loco-regional anaesthetic technique

  14. Drugs_neuromuscular blocking agents

    Time frame: Perioperative

    Use of neuromuscular blocking agents during anesthesia

  15. Drugs_opioids

    Time frame: Perioperative

    Use of opioids during anesthesia

  16. Drugs_hypnotics

    Time frame: Perioperative

    Use of hypnotics during anesthesia

  17. Drugs_adjuvant analgesics

    Time frame: Perioperative

    Use of adjuvant analgesics during anesthesia

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • University Hospital, Montpellier

Registry information

Official study title

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

Acronym: Extub_Loca

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.