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NCT Number: NCT06296173

Open Lung Protective Extubation Following General Anesthesia

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.

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Key information

Conditions

Intra-abdominal Surgery Anesthesia Atelectasis Lung Diseases Lung Injury Pulmonary Atelectasis Respiratory Tract Diseases Thoracic Injuries Ventilator-Induced Lung Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protective "open-lung" extubation

Other

Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP

Conventional extubation

Other

Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP

Primary outcomes

  1. Average weekly patient recruitment rate

    Time frame: Every week. At the end of the study (average 9 months) at the study level.

    Achieve a weekly patient recruitment rate of 2 patients per week per center

  2. Protocol adherence rate

    Time frame: At the end of surgery for individual assessments. At the end of the study (average 9 months) at the study level.

    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.

  3. Postoperative pulmonary complications outcome completion rate

    Time frame: At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level.

    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.

Secondary outcomes

  1. Accuracy of self-reported protocol adherence compared to directly observed protocol adherence

    Time frame: At the end of the surgery

    Following emergence from general anesthesia, treating anesthesiologists will complete the same four-point scoring sheet as the research assistant to self-report protocol adherence.

  2. Postoperative pulmonary complications

    Time frame: At postoperative day 7

    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.

  3. Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit

    Time frame: At postoperative day 7 or hospital discharge (earliest of the two)

    Obtained from the electronic medical record or the handwritten vital signs sheet. Calculated as %.h-1

  4. Quality of recovery

    Time frame: At postoperative day 1

    Evaluated using the QoR-15 questionnaire completed at the bedside.

  5. Discharge disposition

    Time frame: At postoperative day 30

    Location to which patient is discharged (e.g., home, long term care facility, etc.) Assessed during telephone interview and using administrative data. We will

  6. Days alive and out of hospital

    Time frame: At postoperative day 30

    Assessed during telephone interview and using administrative data

  7. Health-related quality of life

    Time frame: At postoperative day 90

    Evaluated using the EQ-5D-5L questionnaire completed during a telephone interview

Other outcomes

  1. Lowest oxygen saturation post-extubation in the operating room

    Time frame: At operating room exit

    Lowest SpO2 in the operating room during emergence

  2. Time in minutes with oxygen saturation < 85% post-extubation in the operating room

    Time frame: At operating room exit

    Time with SpO2 < 85% in the operating room during emergence

  3. Re-intubation rate in the operating room and in the post-anesthesia care unit

    Time frame: At discharge from the post-anesthesia care unit

    Re-intubation in the operating room during emergence or in the post-anesthesia care unit

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Amzallag, MSC

CONTACT

[email protected]

514-890-8000

Martin Girard, MD

CONTACT

[email protected]

514-890-8000

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • CHU de Quebec-Universite Laval
  • Canadian Institutes of Health Research (CIHR)
  • The Ottawa Hospital
  • University Health Network, Toronto

Registry information

Official study title

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

Acronym: OLEXT-3

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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