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Procedure

Open-Lung Extubation for Collapsed Lung Prevention (OLEXT-3 Trial)

N/A

Recruiting

Led By Martin Girard, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every week. at the end of the study (average 9 months) at the study level.

Awards & highlights

No Placebo-Only Group

Summary

"This trial investigates the impact of different ventilation strategies on postoperative complications. Studies show conflicting results on the effectiveness of "open lung" ventilation in preventing atelectasis. It is important to develop evidence-based

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed, but may include typical risks associated with extubation such as discomfort, coughing, or difficulty breathing immediately following tube removal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every week. at the end of the study (average 9 months) at the study level.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every week. at the end of the study (average 9 months) at the study level.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every week. at the end of the study (average 9 months) at the study level. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average weekly patient recruitment rate

Postoperative pulmonary complications outcome completion rate

Protocol adherence rate

Secondary study objectives

Accuracy of self-reported protocol adherence compared to directly observed protocol adherence

Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit

Days alive and out of hospital

+4 more

Other study objectives

Lowest oxygen saturation post-extubation in the operating room

Re-intubation rate in the operating room and in the post-anesthesia care unit

Time in minutes with oxygen saturation < 85% post-extubation in the operating room

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Open lung extubationExperimental Treatment1 Intervention

Before emergence from anesthesia, the patient will be positioned at 30 degrees, and oropharyngeal secretions will be suctioned. Anesthetic gas or intravenous agents will be stopped. Oxygen levels will be set to 50% with a fresh gas flow of at least 10 L/min. Ventilation mode will switch to pressure support adjusted to achieve similar volumes as controlled ventilation. PEEP levels will remain unchanged, while the minimum respiratory rate will decrease by 4 breaths/min. The inspiratory flow for triggering will be set at 2 L/min.

Group II: Conventional extubationActive Control1 Intervention

Before emergence from anesthesia, the patient will be kept supine and oropharyngeal secretions will be suctioned. Anesthetic gas or IV agents will be stopped. Oxygen concentration will be inscreased to 100% with a fresh gas flow ≥10 L/min. The ventilator will be halted, APL valve opened to atmosphere, and the patient manually ventilated with the reservoir bag until spontaneous breathing resumes, followed by manual assistance as deemed necessary by the anesthesiologist.

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