Open Lung Protective Extubation Following General Anesthesia

Anesthesia Clinical Trial

— OLEXT-3  

Official title:

Open Lung Protective Extubation Following General Anesthesia: the OLEXT-3 Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296173
• Other study ID #: MP-02-2024-12094
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Martin Girard, MD
• Phone: 514-890-8000
• Email: martin.girard[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.

Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.

Description:

The aim of this study is to establish the feasibility of a multicenter randomized controlled clinical trial comparing two clinical strategies called "open lung" and "conventional" during extubation. The investigators also aim to estimate the rates of postoperative pulmonary complications in the two intervention groups.

METHODS

A multicenter internal pilot, prospective, randomized, allocation-concealed and controlled assessor-blinded study. Two hundred sixteen patients scheduled to undergo elective intra-abdominal surgery requiring general anesthesia and planned hospitalization at four Canadian hospitals, and at moderate or high risk of postoperative pulmonary complications according to the ARISCAT score will be recruited. Following the administration of standardized mechanical ventilation and after obtaining consent, participants will be randomly assigned to two groups:

Group A: Intervention group, "open lung" extubation strategy Group B: Control group, "conventional" extubation strategy.

The rate of adherence to the extubation protocol, the weekly patient recrutement rate and the 7-day postoperative pulmonary complications outcome completion rate will be measured. We will only report secondary efficacy outcome in aggregate as they will be rolled over to the definitive trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: April 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (18 years of age or over)

• Elective intra-abdominal surgery under general anesthesia.

• Moderate or high risk of postoperative pulmonary complication according to the ARISCAT score (score of 26 or more)

• Planned postoperative hospitalization

Exclusion Criteria:

• Expected or known difficult intubation according to the treating anesthesiologist

• Postoperative mechanical ventilation (planned or unplanned)

• General anesthesia performed outside the main operating room

Related Conditions & MeSH terms

• Anesthesia
• Atelectasis
• Intra-abdominal Surgery
• Lung Injury
• Pulmonary Atelectasis
• Ventilator-Induced Lung Injury
• Wounds and Injuries

Intervention

Other:
• Protective "open-lung" extubation
Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP
• Conventional extubation
Emergence using 100% FiO2, dorsal decubitus position with manual bag ventilation without PEEP

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Québec - Université Laval	Québec
Canada	Unity Health Network	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Canadian Institutes of Health Research (CIHR), CHU de Quebec-Universite Laval, The Ottawa Hospital, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lowest oxygen saturation post-extubation in the operating room	Lowest SpO2 in the operating room during emergence	At operating room exit
Other	Time in minutes with oxygen saturation < 85% post-extubation in the operating room	Time with SpO2 < 85% in the operating room during emergence	At operating room exit
Other	Re-intubation rate in the operating room and in the post-anesthesia care unit	Re-intubation in the operating room during emergence or in the post-anesthesia care unit	At discharge from the post-anesthesia care unit
Primary	Average weekly patient recruitment rate	Achieve a weekly patient recruitment rate of 2 patients per week per center	Every week. At the end of the study (average 9 months) at the study level.
Primary	Protocol adherence rate	Assess adherence to a protocol during emergence from anesthesia, monitoring four criteria (proper positioning (dorsal decubitus or semi-sitting position), correct FiO2 (100% or 50%), appropriate ventilatory mode (manual or pressure support ventilation), and proper end-expiratory pressure (zero or preserved end-expiratory pressure), and noting deviations, with adherence defined as successful performance of all criteria during extubation.	At the end of surgery for individual assessments. At the end of the study (average 9 months) at the study level.
Primary	Postoperative pulmonary complications outcome completion rate	Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition.	At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level.
Secondary	Accuracy of self-reported protocol adherence compared to directly observed protocol adherence	Following emergence from general anesthesia, treating anesthesiologists will complete the same four-point scoring sheet as the research assistant to self-report protocol adherence.	At the end of the surgery
Secondary	Postoperative pulmonary complications	Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition.	At postoperative day 7
Secondary	Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit	Obtained from the electronic medical record or the handwritten vital signs sheet. Calculated as %.h-1	At postoperative day 7 or hospital discharge (earliest of the two)
Secondary	Quality of recovery	Evaluated using the QoR-15 questionnaire completed at the bedside.	At postoperative day 1
Secondary	Discharge disposition	Location to which patient is discharged (e.g., home, long term care facility, etc.) Assessed during telephone interview and using administrative data. We will	At postoperative day 30
Secondary	Days alive and out of hospital	Assessed during telephone interview and using administrative data	At postoperative day 30
Secondary	Health-related quality of life	Evaluated using the EQ-5D-5L questionnaire completed during a telephone interview	At postoperative day 90