Clinical trial NCT04993001: Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications
Official title: Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications Compared to a Conventional Extubation Strategy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Pulmonary Atelectasis
Complication of Anesthesia
Keywords: Open lung extubation strategy
Postoperative pulmonary complications
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, single-center, randomized, triple-blind controlled study
Primary purpose: PREVENTION

Brief 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.

Detailed 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 and verify the hypothesis that the "open lung" extubation strategy improves postoperative lung aeration as measured by the quantitative Lung Ultrasound Score compared to a conventional extubation strategy.

Methods

A pilot, prospective, randomized and controlled triple-blind study. Sixty-nine patients scheduled to undergo elective surgery at the CHUM 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: Intervention group, "open lung" extubation strategy and Control group, "conventional" extubation strategy.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age requiring elective surgery under general anesthesia and hospitalization.
* Patients with a moderate or high risk of postoperative pulmonary complication according to the ARISCAT score (score of 26 or more)

Exclusion Criteria:

* Expected or known difficult intubation according to the treating anesthesiologist
* Postoperative mechanical ventilation (planned or unplanned)
* Neuromuscular disease
* Intrathoracic surgery
* Respiratory failure, sepsis or mechanical ventilation in the month preceding anesthesia
* Pregnancy
* Patient refusal
* Ultrasound sub-study:

  * Body mass index greater than 40 kg.m-2
  * Extensive postoperative chest dressings
* Clinician's refusal to participate

Primary outcomes:
measure: Protocol adherence rate
timeFrame: At the end of the surgery
Secondary outcomes:
measure: Number of eligible patients per week
timeFrame: Through study completion, an average of 1 year
measure: Rate of consent to participate in the protocol
timeFrame: Through study completion, an average of 1 year
measure: Rate of missing values
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Estimated baseline rates of postoperative respiratory complications in the two intervention groups
timeFrame: 7 days following the patient enters the recovery room
measure: Comparison of pulmonary aeration using the qLUS score in the two intervention groups
timeFrame: 15 minutes after the patient enters the recovery room
measure: Re-intubation rate in the operating room
timeFrame: At the end of the surgery
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Martin Girard, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: