Impact of an Open Lung Extubation Strategy on Postoperative Pulmonary Complications

NCT04993001 | Completed

• 1 other identifier: 21.126
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Pulmonary Atelectasis; Complication of Anesthesia

Keywords

Open lung extubation strategy; Postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

• Protocol adherence rate

  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.

  At the end of the surgery

Secondary Outcomes (3)

• Number of eligible patients per week

  Through study completion, an average of 1 year

• 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

Other Outcomes (3)

• Estimated baseline rates of postoperative respiratory complications in the two intervention groups

  7 days following the patient enters the recovery room

• Comparison of pulmonary aeration using the qLUS score in the two intervention groups

  15 minutes after the patient enters the recovery room

• Re-intubation rate in the operating room

  At the end of the surgery

Study Arms (2)

Emergence from general anesthesia with an open lung extubation strategy

ACTIVE COMPARATOR

Other: Open lung extubation

Emergence from general anesthesia with a conventional extubation strategy

PLACEBO COMPARATOR

Other: Conventional extubation

Interventions

Open lung extubation OTHER

Before starting emergence from anesthesia, the patient will be transferred to their hospital bed or stretcher and seated at 30 degrees. Secretions from the patients' oropharynx will be suctioned. To prevent the patient from coughing, the anesthetic gas or intravenous agent will be stopped after the transfer and suction procedure are completed. The FiO2 will be maintained at the same level or increased to 50% (minimum FiO2) with a fresh gas flow rate greater than or equal to 10 L.min-1. The ventilation mode will be changed to pressure support. The level of pressure support will be modified by the anesthesiologist to generate the same volumes as with controlled ventilation. The PEEP will be maintained at the same level. The minimum respiratory rate will be reduced by 4 min-1. The inspiratory flow for triggering will be 2 L.min-1.

Emergence from general anesthesia with an open lung extubation strategy

Conventional extubation OTHER

Before starting emergence from anesthesia, the patient will be transferred to his hospital bed or stretcher and kept in the supine position. Secretions from the patients' oropharynx will be suctioned. To prevent the patient from coughing, the anesthetic gas or intravenous agent will be stopped after the transfer and suction procedure are completed. The FiO2 will be increased to 100% with a fresh gas flow rate greater than or equal to 10 L.min-1. The ventilator will be stopped with the APL valve open to atmosphere. The patient will be manually ventilated with the reservoir bag until spontaneous ventilation resumes. Then, the patient may be manually assisted if the treating anesthesiologist deems it necessary.

Emergence from general anesthesia with a conventional extubation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (1)

• Girard J, Zaouter C, Moore A, Carrier FM, Girard M. Effects of an open lung extubation strategy compared with a conventional extubation strategy on postoperative pulmonary complications after general anesthesia: a single-centre pilot randomized controlled trial. Can J Anaesth. 2023 Oct;70(10):1648-1659. doi: 10.1007/s12630-023-02533-z. Epub 2023 Jul 27.

  PMID: 37498442 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martin Girard, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, single-center, randomized, triple-blind controlled study

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 6, 2021
• Study Start: November 3, 2021
• Primary Completion: December 17, 2021
• Study Completion: January 17, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)