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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06249659
Other study ID # IRB-MTP_2022_04_202201100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date February 1, 2023

Study information

Verified date January 2024
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 756
Est. completion date February 1, 2023
Est. primary completion date January 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Extubation in operative room
Extubation takes place in operative room
Extubation in post anesthesia care unit
Extubation takes place in post anesthesia care unit

Locations

Country Name City State
France Clermont-Ferrand University Hospital Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary Incidence of oxygen support requirement_Day-1 Oxygen support requirement on the first day post-extubation First postoperative day
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Reversal_NMBA Incidence of pharmacologic reversal of neuromuscular blocking agents From end of anesthesia until extubation, assessed up to 2 hours
Secondary Loco-regional anaesthetic technique Use of any loco-regional anaesthetic technique Perioperative
Secondary Drugs_neuromuscular blocking agents Use of neuromuscular blocking agents during anesthesia Perioperative
Secondary Drugs_opioids Use of opioids during anesthesia Perioperative
Secondary Drugs_hypnotics Use of hypnotics during anesthesia Perioperative
Secondary Drugs_adjuvant analgesics Use of adjuvant analgesics during anesthesia Perioperative
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