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Impact of Extubation Location After Surgery on Perioperative Times

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06249659
Acronym
Extub_Loca
Enrollment
756
Registered
2024-02-08
Start date
2020-09-01
Completion date
2023-02-01
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

General anesthesia, Extubation, Intubation, Time, Complications

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.

Interventions

PROCEDUREExtubation in operative room

Extubation takes place in operative room

PROCEDUREExtubation in post anesthesia care unit

Extubation takes place in post anesthesia care unit

Sponsors

University Hospital, Montpellier
CollaboratorOTHER
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Additional operative room occupancy time associated with awakening and extubationFrom end of procedure until extubation, assessed up to 2 hoursTime between dressing application (or end of procedure if there was no cutaneous effraction) and discharge from the OR

Secondary

MeasureTime frameDescription
Time from the end of anaesthesia drug administration to extubationFrom end of anesthesia drug administration until extubation, assessed up to 2 hoursTime from the end of anaesthesia drug administration to extubation
Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubationFrom end of procedure until extubation, assessed up to 2 hoursTime from the end of the surgical procedure (closure of surgical site and dressing placement) 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 hoursTime 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 locationFrom end of procedure until next procedure in the same room, assessed up to one dayImpact of sequencing of operating programme in the room concerned on extubation location
Incidence of oxygen support requirement_Day-1First postoperative dayOxygen support requirement on the first day post-extubation
Reported post-operative pulmonary complications_Day7Seven first postoperative daysReported 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)
Oxygen therapy_PACUFrom end of procedure until discharge to surgical ward, assessed up to 6 hoursUse of any rescue oxygen therapy after extubation in post-anesthesia care unit
Hypotension_PACUFrom end of procedure until discharge to surgical ward, assessed up to 6 hoursHypotension occurrence (as defined by a systolic blood pressure below 90 mmHg and/or a mean arterial pressure below 65 mmHg)
Drugs_hypnoticsPerioperativeUse of hypnotics during anesthesia
Hypoxemia_PACUFrom end of procedure until discharge to surgical ward, assessed up to 6 hoursDesaturation occurrence defined as a drop of SpO2 below 96% (15), either early (within 5 min post-extubation) or delayed
NMBA_PACUFrom end of procedure until discharge to surgical ward, assessed up to 6 hoursPresence of residual neuromuscular blockade as illustrated by train of four below 90%
Reversal_NMBAFrom end of anesthesia until extubation, assessed up to 2 hoursIncidence of pharmacologic reversal of neuromuscular blocking agents
Loco-regional anaesthetic techniquePerioperativeUse of any loco-regional anaesthetic technique
Drugs_neuromuscular blocking agentsPerioperativeUse of neuromuscular blocking agents during anesthesia
Drugs_opioidsPerioperativeUse of opioids during anesthesia
Drugs_adjuvant analgesicsPerioperativeUse of adjuvant analgesics during anesthesia
Bradycardia_PACUFrom end of procedure until discharge to surgical ward, assessed up to 6 hoursBradycardia occurrence (as defined as a drop of cardiac frequency below 50 beats.min-1)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026