Impact of Extubation Location After Surgery on Perioperative Times

Surgery Clinical Trial

— Extub_Loca  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249659
• Other study ID #: IRB-MTP_2022_04_202201100
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Complication,Postoperative
• Extubation
• Intubation
• Postoperative Complications
• Respiratory Failure
• Respiratory Insufficiency
• Surgery

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