Effects of different oxygen masks and bag‑valve setups on oxygen levels before airway procedures

Physiological Effects of Different Preoxygenation Strategies in Adults and Children: A Comparative Study of NRM and BVM With and Without PEEP

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

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 5 Years to 75 Years
• Sex: All
• Sponsor: Institute of Mountain Emergency Medicine (other)
• Locations: 1 site (Bolzano, BZ)
• Trial ID: NCT07564050 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Prior work suggests PEEP‑providing techniques can improve oxygenation, but direct controlled comparisons between common preoxygenation devices—especially including pediatric data—are limited.

Eligibility 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 this trial is running

Bolzano, BZ

• 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

Conditions: Preoxygenation, Bag-valve mask, Non-rebreather mask, Positive end-expiratory pressure, Fraction of inspired oxygen, Respiratory physiology