Effects of different oxygen masks and bag‑valve setups on oxygen levels before airway procedures
Official title: Physiological Effects of Different Preoxygenation Strategies in Adults and Children: A Comparative Study of NRM and BVM With and Without PEEP
Run by Institute of Mountain Emergency Medicine · NCT07564050 · Data updated 2026-11-12
This test will see if non‑rebreather masks, bag‑valve masks (with or without added pressure), and nasal cannulas deliver different oxygen levels and breathing pressures in healthy adults and children aged 5–12.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Institute of Mountain Emergency Medicine Academic / other |
| Locations | 1 site (Bolzano, BZ) |
| Status | Recruiting |
| Started | May 23, 2026 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT07564050 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults with ASA physical status ≤2 and children aged 5–12 with ASA ≤2 who can provide informed consent (or have guardian consent) are the intended participants.
✕Probably not a fit
People with BMI ≥30, known airway abnormalities, active airway infection, pregnancy, ASA >2, or those unable to give consent are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized crossover study enrolls healthy adult volunteers and children aged 5–12 to undergo short (about 3‑minute) preoxygenation sessions with commonly used devices. Participants will use non‑rebreather masks, bag‑valve masks (with and without PEEP where applicable), and nasal cannulas in different combinations while researchers measure inspired oxygen fraction, airway pressures, inspiratory effort, lung ventilation, and cardiac responses. The protocol compares device performance and the physiologic effects of delivered FiO2 versus generated positive end‑expiratory pressure under controlled conditions. Data from adults and children will be analyzed separately to address pediatric gaps in current evidence.
Why it matters
Potential benefit: If successful, the results could help clinicians choose preoxygenation devices that better increase oxygen reserves and reduce the risk of hypoxia during airway management.
How similar studies have gone: Prior work suggests PEEP‑providing techniques can improve oxygenation, but direct controlled comparisons between common preoxygenation devices—especially including pediatric data—are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with an American Society of Anesthesiologists (ASA) physical status score ≤ 2 * Children aged 5 to 12 years with an ASA physical status score ≤ 2 * Ability (or legal guardian ability) to provide written informed consent Exclusion Criteria: * Children aged \< 5 years or 13 to 18 years * ASA physical status score \> 2 * Body mass index (BMI) ≥ 30 kg/m² * Known airway pathology or anatomical abnormality that could affect mask fit, ventilation, or oxygenation * Presence of an active airway infection at the time of the study * Pregnancy * Refusal or inability to provide informed consent
Where it's running
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Eurac research, Institute of mountain emergency medicine
Bolzano, Bz, Italy Recruiting
Study contacts
- Principal investigator: Simon Rauch — Eurac research, Institute of mountain emergency medicine
- Study coordinator: Giulia Roveri, MD
- Email: giulia.roveri@eurac.edu
- Phone: +390471055115
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.