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Procedure
Lower Oxygen Concentration for Preventing Collapsed Lung (RESPIRA-EIT Trial)
N/A
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Elective surgery with general anesthesia and endotracheal intubation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the cov is measured at six points: pre-induction, post-intubation, pre-washout, pre-extubation, 1 min post-extubation, and 60 min post-extubation in the pacu. the primary outcome is the difference between pre-induction and 1 min post-extubation.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study whether using a lower oxygen concentration (70% compared to 100%) before removing a breathing tube reduces the risk of lung tissue collapse (atelectasis) in patients under anesthesia
Who is the study for?
This trial is for adults over 18 who are having elective surgery with general anesthesia and endotracheal intubation, lasting between 1-5 hours. They must consent to participate in the study.
What is being tested?
The study tests if using a lower oxygen concentration (70%) before removing a patient's breathing tube reduces lung collapse compared to the standard high oxygen level (100%). Patients are randomly assigned to one of these two approaches.
What are the potential side effects?
Potential side effects may include difficulty breathing or low blood oxygen levels after extubation. The risk of re-intubation or needing non-invasive ventilation post-surgery might also be affected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a surgery that requires being put to sleep and a breathing tube.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the length of stay in the pacu is measured in minutes from admission to discharge from the pacu.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the length of stay in the pacu is measured in minutes from admission to discharge from the pacu.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The shift of Center of Ventilation (CoV), measured through Electrical Impedance Tomography (EIT) in %.
Secondary study objectives
Length of stay in the PACU
Minutes of hypoxemia in the first 60 minutes after extubation
Re-intubation or the need for unplanned non-invasive ventilation within 7 days.
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Control groupActive Control1 Intervention
Ventilating the patient with 100% oxygen concentration during the wash out phase, before extubation
Group II: Intervention groupActive Control1 Intervention
Ventilating the patient with 70% oxygen concentration during the wash out phase, before extubation
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,937 Total Patients Enrolled
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