Clinical trial NCT06249659: Impact of Extubation Location After Surgery on Perioperative Times
Official title: Impact of Extubation Location After Surgery on Perioperative Times. A Prospective Multicenter Observational Study. Extub_Loca Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Intubation
Surgery
Extubation
Respiratory Failure
Complication,Postoperative
Keywords: General anesthesia
Extubation
Intubation
Time
Complications
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Montpellier
First posted: 2024-02-08
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient requiring endotracheal extubation after general anesthesia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Additional operative room occupancy time associated with awakening and extubation
timeFrame: From end of procedure until extubation, assessed up to 2 hours
Secondary outcomes:
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
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
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
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
measure: Incidence of oxygen support requirement_Day-1
timeFrame: First postoperative day
measure: Reported post-operative pulmonary complications_Day7
timeFrame: Seven first postoperative days
measure: Oxygen therapy_PACU
timeFrame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
measure: Hypotension_PACU
timeFrame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
measure: Bradycardia_PACU
timeFrame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
measure: Hypoxemia_PACU
timeFrame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
measure: NMBA_PACU
timeFrame: From end of procedure until discharge to surgical ward, assessed up to 6 hours
measure: Reversal_NMBA
timeFrame: From end of anesthesia until extubation, assessed up to 2 hours
measure: Loco-regional anaesthetic technique
timeFrame: Perioperative
measure: Drugs_neuromuscular blocking agents
timeFrame: Perioperative
measure: Drugs_opioids
timeFrame: Perioperative
measure: Drugs_hypnotics
timeFrame: Perioperative
measure: Drugs_adjuvant analgesics
timeFrame: Perioperative
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
Study officials:
affiliation: Clermont-Ferrand University Hospitals
name: Thomas Godet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montpellier University Hospitals
name: Audrey De Jong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: