Open-Lung Extubation for Collapsed Lung Prevention

(OLEXT-3 Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Martin Girard, MD, FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Difficult intubation, Postoperative ventilation, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Protective 'open-lung' extubation for preventing collapsed lung?

Research on lung protective strategies, like the open lung approach, shows they can reduce lung injury and improve outcomes in conditions like adult respiratory distress syndrome (ARDS). These strategies help keep the lungs open and prevent damage during mechanical ventilation, which may support their use in preventing collapsed lungs.

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Is the open-lung extubation approach generally safe for humans?

Research on lung-protective ventilation, which includes strategies similar to open-lung extubation, suggests it is generally safe and may reduce complications like lung inflammation and sepsis in surgical patients.

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What makes the Protective 'open-lung' extubation treatment unique for preventing collapsed lung?

The Protective 'open-lung' extubation treatment is unique because it focuses on keeping the lung open during and after extubation by using techniques like high-pressure recruitment maneuvers and maintaining positive end-expiratory pressure, which are not typically part of standard extubation procedures.

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Eligibility Criteria

This trial is for patients who have undergone abdominal surgery and are at risk of lung complications like collapsed lungs or injury from a ventilator. Participants must not have any conditions that would exclude them from the study, as detailed in the provided eligibility criteria.

Inclusion Criteria

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

I am scheduled for elective surgery in my abdomen with general anesthesia.

I am 18 years old or older.

Exclusion Criteria

Expected or known difficult intubation according to the treating anesthesiologist

I will need or have needed help to breathe after surgery.

I had general anesthesia in a place other than the main operating room.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo elective intra-abdominal surgery with either 'open lung' or 'conventional' extubation strategy

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for postoperative pulmonary complications and other outcomes

7 days

1 visit (in-person), telephone interviews

Extended Follow-up

Participants' health-related quality of life and discharge disposition are assessed

90 days

Telephone interviews

Participant Groups

The study is testing two ways to remove breathing tubes after general anesthesia: the usual method versus a 'protective open-lung' approach designed to keep lungs well-aerated and potentially reduce post-surgery lung issues.

Group I: Open lung extubation Experimental Treatment 1 Intervention

At the beginning of emergence, patients will be positioned with the head of the bed elevated to at least 30 degrees and the FiO2 will be set at 50%. At the resumption of spontaneous ventilation or earlier at the discretion of the anesthesiologist, the ventilator will be set to pressure support ventilation mode for the rest of the emergence procedure. The pressure support level will be adjusted to obtain a volume similar to the one used prior to emergence. PEEP will be left unchanged. Anesthesiologists will be instructed not to switch off the ventilator until the patient is extubated.

Group II: Conventional extubation Active Control 1 Intervention

At the beginning of emergence, patients will be positioned in a dorsal decubitus position and the FiO2 will be set at 100%. At the resumption of spontaneous ventilation or earlier at the discretion of the anesthesiologist, the ventilator will be switched off for the rest of the emergence procedure with the adjustable pressure-limiting valve open to atmosphere. Manual ventilation or assistance will be allowed, but the adjustable pressure-limiting valve will be reopened when pausing manual ventilation or assistance.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

CHU de Québec - Université Laval Québec, Canada

The Ottawa Hospital Ottawa, Canada

Unity Health Network Toronto, Canada

Centre Hospitalier de l'Université de Montréal (CHUM) Montréal, Canada

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM) Lead Sponsor

Canadian Institutes of Health Research (CIHR) Collaborator

CHU de Quebec-Universite Laval Collaborator

The Ottawa Hospital Collaborator

University Health Network, Toronto Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. [2018] The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation.

2. England pubmed.ncbi.nlm.nih.gov

Lung protective ventilatory strategies in acute lung injury and acute respiratory distress syndrome: from experimental findings to clinical application. [2020] This review addresses the physiological background and the current status of evidence regarding ventilator-induced lung injury and lung protective strategies. Lung protective ventilatory strategies have been shown to reduce mortality from adult respiratory distress syndrome (ARDS). We review the latest knowledge on the progression of lung injury by mechanical ventilation and correlate the findings of experimental work with results from clinical studies. We describe the experimental and clinical evidence of the effect of lung protective ventilatory strategies and open lung strategies on the progression of lung injury and current controversies surrounding these subjects. We describe a rational strategy, the open lung strategy, to accomplish an open lung, which may further prevent injury caused by mechanical ventilation. Finally, the clinician is offered directions on lung protective ventilation in the early phase of ARDS which can be applied on the intensive care unit.

3. Italy pubmed.ncbi.nlm.nih.gov

Lung protective ventilation in ARDS: the open lung maneuver. [2020] This review addresses the current state of lung protective strategies and their physiological rationale. Lung protective ventilation can reduce mortality in adult respiratory distress syndrome (ARDS) patients. We review the latest knowledge on the progression of lung injury by mechanical ventilation. Results from clinical studies on mechanical ventilation are compared with results obtained in experimental studies. Furthermore, we discuss possible future improvements to mechanical ventilation; especially the open lung maneuver. The rationale behind the open lung maneuver and steps to accomplish an open lung are described, as well as data from animal and human studies. Finally, guidelines for future strategies and/or investigations are presented.

4. United States pubmed.ncbi.nlm.nih.gov

Ventilator-induced lung injury: in vivo and in vitro mechanisms. [2020] A lung-protective ventilator strategy significantly reduces mortality in patients with acute lung injury. Substantial progress has been made in understanding how mechanical stress can injure the lung, both in terms of alterations in barrier properties of the pulmonary endothelium and epithelium as well as in stimulating proinflammatory responses of macrophages and neutrophils.

5. United States pubmed.ncbi.nlm.nih.gov

Lung recruitment. [2020] It has become increasingly clear that a lung protective ventilatory strategy during adult respiratory distress syndrome/acute lung injury has a positive effect on outcome. Lung recruitment is a major component of this strategy. High-pressure recruitment maneuvers and prone positioning can open the lung; however, once the lung is opened, it must be kept open with appropriate levels of positive end-expiratory pressure. For both of these techniques to be effective, they must be used early in the course of adult respiratory distress syndrome/acute lung injury.

6. United States pubmed.ncbi.nlm.nih.gov

A Lower Tidal Volume Regimen during One-lung Ventilation for Lung Resection Surgery Is Not Associated with Reduced Postoperative Pulmonary Complications. [2022] Protective ventilation may improve outcomes after major surgery. However, in the context of one-lung ventilation, such a strategy is incompletely defined. The authors hypothesized that a putative one-lung protective ventilation regimen would be independently associated with decreased odds of pulmonary complications after thoracic surgery.

7. England pubmed.ncbi.nlm.nih.gov

Initial ventilator settings for critically ill patients. [2021] The lung-protective mechanical ventilation strategy has been standard practice for management of acute respiratory distress syndrome (ARDS) for more than a decade. Observational data, small randomized studies and two recent systematic reviews suggest that lung protective ventilation is both safe and potentially beneficial in patients who do not have ARDS at the onset of mechanical ventilation. Principles of lung-protective ventilation include: a) prevention of volutrauma (tidal volume 4 to 8 ml/kg predicted body weight with plateau pressure

8. England pubmed.ncbi.nlm.nih.gov

Intra-operative adherence to lung-protective ventilation: a prospective observational study. [2022] Lung-protective ventilation in patients with acute respiratory distress syndrome improves mortality. Adopting this strategy in the perioperative period has been shown to reduce lung inflammation and postoperative pulmonary and non-pulmonary sepsis complications in patients undergoing major abdominal surgery. We conducted a prospective observational study into the intra-operative ventilation practice across the West Midlands to assess the use of lung-protective ventilation.

9. United States pubmed.ncbi.nlm.nih.gov

A randomized comparison of different ventilator strategies during thoracotomy for pulmonary resection. [2013] Protective lung ventilation is reported to benefit patients with acute respiratory distress syndrome. It is not known whether protective lung ventilation is also beneficial to patients undergoing single-lung ventilation for elective pulmonary resection.

10. England pubmed.ncbi.nlm.nih.gov

Treatment of acute total atelectasis. Use of a double lumen tube. [2019] Three cases are described of complete collapse of a lung in the absence of bronchial obstruction. The condition was treated by the application of a sustained high pressure (6 kPa) to the affected lung through one limb of a double lumen bronchial tube whilst intermittent positive pressure ventilation was continued through the other limb.

11. United States pubmed.ncbi.nlm.nih.gov

Sequential bilateral lung isolation with a single bronchial blocker. [2015] Sequential bilateral lung separation and selective lung collapse can be accomplished with either a double-lumen tube, a single bronchial blocker (BB) that must be repositioned during the operation, or by using 2 BBs, 1 placed in each main bronchus. We provided sequential bilateral lung collapse using a single BB without the need to reposition during surgery.

12. India pubmed.ncbi.nlm.nih.gov

Expanding unilateral lung collapse using airway pressure release ventilation applied independently to the collapsed lung through the double-lumen endotracheal tube. [2022] Unilateral lung collapse (ULC) is a clinical challenge in the intensive care unit and requires sophisticated treatment approaches, especially if the collapse continued over several hours. If not responded to ordinary measures such as postural drainage and bronchoscopy, it may require insertion of a double-lumen endotracheal tube and independent lung ventilation or high-pressure manual re-expansion of the collapsed lung which may result in lung injury. In this article, a safe and gradual re-expansion method using airway pressure release ventilation is presented for the treatment of a ULC.