Open-Lung Extubation for Collapsed Lung Prevention

(OLEXT-3 Trial)

Recruiting at 4 trial locations

Overseen By Eva Amzallag, MSC

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Difficult intubation, Postoperative ventilation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day (surgery)

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent lung collapse after surgery. It compares the usual way of removing a breathing tube with a new "open-lung" method (Protective 'open-lung' extubation) that may keep the lungs better inflated. The goal is to determine if the new method reduces the risk of lung problems post-surgery. Individuals who have undergone planned abdominal surgery and are at risk of lung issues might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance surgical outcomes.

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 prior data suggests that this extubation protocol is safe?

Research shows that "open lung" extubation keeps the lungs filled with air during and after removing a breathing tube, helping to prevent lung collapse post-surgery. Studies indicate that this method aims to reduce issues like parts of the lung collapsing during recovery.

Although specific studies on the side effects of "open lung" extubation are lacking, it relies on common anesthesia practices, suggesting it is likely well-tolerated. The method uses techniques to maintain proper lung function, which are well-known and generally safe. For those considering joining a trial, these methods likely have a safety profile similar to standard practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "open-lung" extubation technique because it offers a novel approach to preventing lung collapse after surgery. Unlike the conventional method that often involves turning off the ventilator and using manual ventilation, the open-lung approach keeps the ventilator on in a pressure support mode. This helps maintain lung volume and potentially reduces the risk of lung collapse. By adjusting the pressure support level to mimic pre-emergence breathing, this method aims to offer a smoother transition and better outcomes for patients.

What evidence suggests that protective 'open-lung' extubation is effective for preventing postoperative pulmonary complications?

Research shows that "open lung" mechanical ventilation can help prevent lung collapse during surgery. Studies indicate that using this lung-protective method in surgeries, such as open heart surgery, reduces complications after the operation. However, these benefits might not last if the lungs aren't kept well-inflated after removing the breathing tube. Imaging studies suggest that the increase in lung air content from "open lung" methods quickly decreases after tube removal. This trial will compare "open lung" extubation, which might reduce lung issues after surgery by keeping the lungs better inflated, with conventional extubation methods. ^{2 3 6 7 8}

Who Is on the Research Team?

Martin Girard, MD, FRCPC

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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 will stay in the hospital after my surgery.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Protective 'open-lung' extubation

Trial Overview

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

CHU de Quebec-Universite Laval

Collaborator

Trials

177

Recruited

110,000+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Implementing a lung protective ventilatory strategy, including lung recruitment techniques, significantly improves outcomes in patients with adult respiratory distress syndrome (ARDS) or acute lung injury.

Early application of high-pressure recruitment maneuvers and prone positioning, along with maintaining adequate positive end-expiratory pressure, is crucial for effectively keeping the lungs open and enhancing patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung recruitment. Kacmarek, RM., Schwartz, DR.[2020]

The study demonstrates that sequential bilateral lung collapse can be effectively achieved using a single bronchial blocker (BB) without the need for repositioning during surgery, simplifying the procedure.

This method offers a practical alternative to traditional techniques involving double-lumen tubes or multiple bronchial blockers, potentially enhancing surgical efficiency and patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential bilateral lung isolation with a single bronchial blocker. Brodsky, JB., Tzabazis, A., Basarb-Tung, J., et al.[2015]

In a study involving 1012 patients undergoing major abdominal surgery, individualized perioperative lung-protective ventilation strategies did not significantly reduce the risk of postoperative pulmonary and systemic complications compared to standard ventilation methods.

The study found that while the open-lung approaches (OLA-iCPAP and OLA-CPAP) were implemented without the need for rescue maneuvers due to hypoxemia, they did not show any advantage over standard oxygen therapy (STD-O2) in preventing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Ferrando, C., Soro, M., Unzueta, C., et al.[2018]

Implementing a lung-protective ventilator strategy has been shown to significantly lower mortality rates in patients suffering from acute lung injury.

Research has advanced our understanding of how mechanical stress from ventilation can harm the lungs by affecting the barrier properties of lung cells and triggering inflammatory responses from immune cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilator-induced lung injury: in vivo and in vitro mechanisms. Matthay, MA., Bhattacharya, S., Gaver, D., et al.[2020]

Lung protective ventilation strategies have been shown to significantly reduce mortality in patients with adult respiratory distress syndrome (ARDS), highlighting their efficacy in critical care settings.

The review discusses the open lung maneuver as a promising technique to improve mechanical ventilation outcomes, supported by both animal and human studies, suggesting it could enhance lung function during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung protective ventilation in ARDS: the open lung maneuver. Haitsma, JJ., Lachmann, B.[2020]

A new method using airway pressure release ventilation offers a safe and gradual approach to re-expand a collapsed lung in cases of unilateral lung collapse (ULC), which is a significant challenge in intensive care settings.

This method may reduce the risk of lung injury compared to traditional high-pressure manual re-expansion techniques, providing a more effective treatment option for patients with prolonged ULC.

NCBI (Pubmed)

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. Saghaei, M.[2022]

In a study of 406 patients undergoing surgery in the West Midlands, none were ventilated using lung-protective ventilation strategies, which are known to improve outcomes in patients with acute respiratory distress syndrome.

The study highlighted that while the majority of patients received volume-controlled ventilation, the use of positive end-expiratory pressure (PEEP) was notably low, suggesting a need for further trials to encourage the adoption of lung-protective ventilation practices in the perioperative setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-operative adherence to lung-protective ventilation: a prospective observational study. Patel, JM., Baker, R., Yeung, J., et al.[2022]

Lung protective ventilatory strategies significantly reduce mortality in patients with adult respiratory distress syndrome (ARDS), highlighting their efficacy in preventing ventilator-induced lung injury.

The review discusses the 'open lung strategy' as a rational approach to maintain lung function and prevent further injury during mechanical ventilation, providing practical guidance for clinicians in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung protective ventilatory strategies in acute lung injury and acute respiratory distress syndrome: from experimental findings to clinical application. Verbrugge, SJ., Lachmann, B., Kesecioglu, J.[2020]

Lung-protective mechanical ventilation is a safe and potentially beneficial strategy for patients without acute respiratory distress syndrome (ARDS), based on observational data and systematic reviews.

This ventilation approach includes specific principles such as using lower tidal volumes (4 to 8 ml/kg), maintaining plateau pressures below 30 cmH2O, and ensuring adequate oxygen levels, making it suitable for both perioperative and critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial ventilator settings for critically ill patients. Kilickaya, O., Gajic, O.[2021]

The study presents three cases of complete lung collapse without bronchial obstruction, highlighting a rare medical condition.

Treatment involved applying sustained high pressure (6 kPa) to the collapsed lung using a double lumen bronchial tube while maintaining ventilation, demonstrating a novel approach to managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acute total atelectasis. Use of a double lumen tube. Murray, JF.[2019]

In a study of 3,232 patients undergoing thoracic surgery with one-lung ventilation, a protective ventilation strategy (defined as low tidal volume and adequate positive end-expiratory pressure) did not significantly reduce the incidence of postoperative pulmonary complications.

Despite an increase in the use of protective ventilation techniques from 5.7% in 2012 to 17.9% in 2016, the overall rate of pulmonary complications remained unchanged, indicating that this approach may not be effective in improving outcomes in this surgical context.

NCBI (Pubmed)

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. Colquhoun, DA., Leis, AM., Shanks, AM., et al.[2022]

In a study of 34 patients undergoing elective pulmonary resection with single-lung ventilation, high tidal volume (Hi-TV) ventilation was associated with improved respiratory parameters, including lower carbon dioxide levels and better lung compliance, without increasing postoperative complications.

The Hi-TV group experienced significantly less atelectasis (lung collapse) on postoperative days 1 and 2 compared to the low tidal volume group, suggesting that Hi-TV may be beneficial in preventing lung complications during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparison of different ventilator strategies during thoracotomy for pulmonary resection. Maslow, AD., Stafford, TS., Davignon, KR., et al.[2013]

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Conclusion: Lung protective strategy during and after cardiac surgery, reduces the postoperative mCPIS in patients undergoing open heart surgery for CABG.

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Open-Lung Extubation for Collapsed Lung Prevention

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.

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This study is a prospective, double-blinded, randomised controlled trial. A total of 1060 patients at intermediate or high risk for PPCs, scheduled to undergo ...