Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications

Not Applicable

Completed

• Conditions: Anesthesia; Pulmonary Atelectasis; Complication of Anesthesia
• Interventions: Other: Open lung extubation; Other: Conventional extubation

• Registration Number: NCT04993001
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-06
• Study Start: 2021-11-03
• Primary Completion: 2021-12-17
• Study Completion: 2022-01-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emergence from general anesthesia with an open lung extubation strategy	Open lung extubation	-
Emergence from general anesthesia with a conventional extubation strategy	Conventional extubation	-

Primary Outcome Measures

Name	Time	Method
Protocol adherence rate	At the end of the surgery	During emergence from general anesthesia, a research assistant will observe the adherence to the protocol. The adherence rate will be defined as the number of extubations performed according to the protocol and the patient assigned group divided by the total number of awakenings. In the event of a breach of the protocol, the specific elements that led to the deviation will be noted as well as the reasons given by the treating anesthesiologist to justify it.

Secondary Outcome Measures

Name	Time	Method
Rate of consent to participate in the protocol	Through study completion, an average of 1 year
Rate of missing values	Through study completion, an average of 1 year
Number of eligible patients per week	Through study completion, an average of 1 year

Trial Locations

Locations (1)

Centre hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montréal, Quebec, Canada