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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRM - Non-rebreather mask in children 6-12 yrs | Active Comparator | Non-rebreather mask in children 6-12 yrs |
|
| BVM with PEEP in children 6-12 yrs | Active Comparator | Bag valve mask with positive end-expiratory pressure (PEEP) in children 6-12 yrs |
|
| BVM without PEEP in children 6-12 yrs | Active Comparator | Bag valve mask without positive end-expiratory pressure (PEEP) in children 6-12 yrs |
|
| NRM - Non-rebreather mask in normal weight adults | Active Comparator | Non-rebreather mask in normal weight adults |
|
| BVM with PEEP in normal weight adults | Active Comparator | Bag valve mask with positive end-expiratory pressure (PEEP) in normal weight adults |
|
| BVM without PEEP in normal weight adults |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoxygenation | Other | Preoxygenation of volunteers over 3 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 3 minutes of preoxygenation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After 3 minutes of preoxygenation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon Rauch, MD, PhD | Contact | 00393404967398 | simon.rauch@eurac.edu | |
| Giulia Roveri, MD | Contact | giulia.roveri@eurac.edu |
| Name | Affiliation | Role |
|---|---|---|
| Simon Rauch, MD, PhD | Institute of Mountain Emergency Medicine, Eurac Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TerraXCube | Recruiting | Bolzano | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40392551 | Derived | Roveri G, Camporesi A, Hofer A, Kahlen S, Breidt F, Rauch S. Preoxygenation With and Without Positive End-Expiratory Pressure in Lung-Healthy Volunteers: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511569. doi: 10.1001/jamanetworkopen.2025.11569. |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Bag valve mask without positive end-expiratory pressure (PEEP) in normal weight adults |
|
| NRM - Non-rebreather mask in overweight/obese adults | Active Comparator | Non-rebreather mask in overweight/obese adults |
|
| BVM with PEEP in overweight/obese adults | Active Comparator | Bag valve mask with positive end-expiratory pressure (PEEP) in overweight/obese adults |
|
| BVM without PEEP in overweight/obese adults | Active Comparator | Bag valve mask without positive end-expiratory pressure (PEEP) in overweight/obese adults |
|
| 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) |
| 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 | 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 | 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. | Washout phase after the 3 min preoxygenation sessions. |