High-flow nasal oxygen with monitored anesthesia for EBUS bronchoscopy
Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care
NA · The Cooper Health System · NCT05203328
This study will test whether using a Vapotherm high-flow nasal cannula with monitored anesthesia care during EBUS bronchoscopy reduces procedure interruptions, low-oxygen episodes, and procedure time for adults having EBUS.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cooper Health System (other) |
| Locations | 1 site (Camden, New Jersey) |
| Trial ID | NCT05203328 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for EBUS bronchoscopy with monitored anesthesia care at a single center will receive either a Vapotherm high-flow nasal cannula or a regular nasal cannula during the procedure. Researchers will prospectively compare the number and duration of hypoxic episodes, frequency of procedure interruptions, and total procedural time between the two oxygen-delivery methods. Standard inclusion and exclusion criteria apply, excluding patients with prior nasal surgery, significant facial trauma, baseline low oxygen saturation, pregnancy, or anticoagulation that cannot be held. Data will be collected during the procedure and analyzed to determine whether high-flow oxygen improves intra-procedural stability and efficiency.
Who should consider this trial
Good fit: Adults (age >18) with lung cancer scheduled for EBUS bronchoscopy under monitored anesthesia care who meet baseline oxygenation and surgical/anticoagulation criteria are ideal candidates.
Not a fit: Patients with baseline oxygen saturation under 90% on room air, prior nasal surgery or facial fractures, pregnancy, or anticoagulation that cannot be stopped are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, using high-flow nasal oxygen could reduce drops in oxygen levels and interruptions during EBUS, making the procedure safer and potentially shorter.
How similar studies have performed: Other studies of high-flow nasal oxygen during bronchoscopy or procedural sedation have shown reduced desaturation and improved oxygenation in some settings, but evidence specifically for EBUS is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age\>18 years * patient undergoing EBUS bronchoscopy with moderate conscious sedation. Exclusion Criteria: * subjects with previous nasal surgeries * subjects with oxygen saturation \<90% on room air prior to procedure * subjects who are pregnant * subjects with known facial fractures or recent facial trauma * subjects on any anticoagulation that cannot be discontinued prior to the procedure
Where this trial is running
Camden, New Jersey
- Cooper University Hospital — Camden, New Jersey, United States (RECRUITING)
Study contacts
- Study coordinator: Wissam Abouzgheib, MD
- Email: Abouzgheib-Wissam@cooperhealth.edu
- Phone: (800) 826-6737
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.
Conditions: Lung Cancer, EBUS, bronchoscopy, Vapotherm, high-flow nasal cannula, monitored anesthesia care