An interventional study of Preoxygenation in Emergencies and Anesthesia, sponsored by Institute of Mountain Emergency Medicine. Recruiting at 1 site in Italy. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Institute of Mountain Emergency Medicine · Not applicable, Interventional, and Other
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:
Number of participants 15 participants per subgroup, i.e. 45 participants in total.
Inclusion criteria
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 45 is below the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →Institute of Mountain Emergency Medicine is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non-rebreather mask in children 6-12 yrs
Other: Preoxygenation
Bag valve mask with positive end-expiratory pressure (PEEP) in children 6-12 yrs
Other: Preoxygenation
Bag valve mask without positive end-expiratory pressure (PEEP) in children 6-12 yrs
Other: Preoxygenation
Non-rebreather mask in normal weight adults
Other: Preoxygenation
Bag valve mask with positive end-expiratory pressure (PEEP) in normal weight adults
Other: Preoxygenation
Bag valve mask without positive end-expiratory pressure (PEEP) in normal weight adults
Other: Preoxygenation
Non-rebreather mask in overweight/obese adults
Other: Preoxygenation
Bag valve mask with positive end-expiratory pressure (PEEP) in overweight/obese adults
Other: Preoxygenation
Bag valve mask without positive end-expiratory pressure (PEEP) in overweight/obese adults
Other: Preoxygenation
Preoxygenation of volunteers over 3 minutes
Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.
Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions between the three arms.
Time frame: After 3 minutes of preoxygenation
Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions.
Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. ORi ranges from 0.0 to 1.0 and reflects the partial pressure of oxygen in arterial blood (PaO2 80-200).
Time frame: After 3 minutes of preoxygenation
Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)
Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)
Time frame: After 1.5 and 3 minutes of preoxygenation
Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5
Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5
Time frame: Variable, timepoint during the 3 min preoxygenation session
Time to reaching an Oxygen Reserve Index (ORi) =1
Time to reaching an Oxygen Reserve Index (ORi) =1
Time frame: Variable, timepoint during the 3 min preoxygenation session
Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.
Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.
Time frame: Washout phase after the 3 min preoxygenation sessions.
Plan to share: No
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Institute of Mountain Emergency Medicine