Actively Recruiting
Comparison of Three Pre-oxygenation Strategies
Led by Institute of Mountain Emergency Medicine · Updated on 2025-03-28
45
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers. Study endpoints Primary Endpoint: Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions. Secondary endpoints: * Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. * Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT) * Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5 * Time to reaching an Oxygen Reserve Index (ORi) =1 * Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions. Number of participants 15 participants per subgroup, i.e. 45 participants in total. Inclusion criteria * Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II * Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3 * Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day. After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow.
CONDITIONS
Official Title
Comparison of Three Pre-oxygenation Strategies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Normal-weight adults with a BMI of 18.5-24.9 kg/m2 and an ASA Physical Status score of I or II
- Adults with a BMI of 25-39.9 kg/m2 and an ASA Physical Status score less than 3
- Healthy children aged 6 to 12 years with an ASA Physical Status score of I
You will not qualify if you...
- ASA Physical Status score of 3
- Age less than 6 years or between 12 and 18 years
- Pregnant women
- Missing informed consent
- Signs or symptoms of an acute respiratory illness on the study day
AI-Screening
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Trial Site Locations
Total: 1 location
1
TerraXCube
Bolzano, Italy
Actively Recruiting
Research Team
S
Simon Rauch, MD, PhD
CONTACT
G
Giulia Roveri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
9
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