Comparing high and low oxygen levels before extubation to reduce lung collapse
A Randomized Trial Investigating the Impact of High Versus Lower Oxygen Fraction During Extubation on Postoperative Pulmonary Atelectasis Measured With Electrical Impedance Tomography
This study is testing if using lower oxygen levels before taking patients off the ventilator can help prevent lung collapse after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06538740 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of using high versus lower oxygen concentrations prior to extubation on the formation of postoperative pulmonary atelectasis. It is a single-blinded randomized controlled trial that aims to determine if ventilating patients with lower oxygen levels (40% or 70%) before extubation can reduce the risk of lung collapse compared to the standard practice of using 100% oxygen. Patients undergoing elective surgery with general anesthesia will be randomized into two groups, and their lung function will be monitored using electrical impedance tomography (EIT) and SpO₂ recording devices. The study will enroll a total of 48 patients to assess the outcomes effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older undergoing elective surgery requiring general anesthesia and endotracheal intubation.
Not a fit: Patients with severe comorbidities, morbid obesity, or those undergoing cardiac or thoracic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative lung function and reduced risk of atelectasis in patients undergoing general anesthesia.
How similar studies have performed: While the association between high oxygen concentration and atelectasis is known, this specific approach of comparing lower oxygen levels is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Elective surgery with general anesthesia and endotracheal intubation * Expected duration of surgery 1-5 hours * Consent obtained from patient Exclusion Criteria: * Patients with inability to give written informed consent * American Society of Anesthesiologists (ASA) physical status\> IV * Morbid obesity BMI \> 40 * Suspected pregnancy and lactation * Cardiac or thoracic surgery * Patients with thoracic epidural catheters * Patients with active implantable devices, such as pacemakers, cardioverter defibrillators, or neurostimulators * Compromised airways * Impaired oxygenation at baseline or during surgery
Where this trial is running
Boston, Massachusetts
- Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Maximilian S Schaefer, M.D., PhD.
- Email: msschaef@bidmc.harvard.edu
- Phone: (617)-667-3112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.