NCT06370689 Comparison of Three Pre-oxygenation Strategies
| NCT ID | NCT06370689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Mountain Emergency Medicine |
| Condition | Emergencies |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2024-05-23 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Normal-weight adults (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
Contact & Investigator
Simon Rauch, MD, PhD
PRINCIPAL INVESTIGATOR
Institute of Mountain Emergency Medicine, Eurac Research
Frequently Asked Questions
Who can join the NCT06370689 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Emergencies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06370689 currently recruiting?
Yes, NCT06370689 is actively recruiting participants. Contact the research team at simon.rauch@eurac.edu for enrollment information.
Where is the NCT06370689 trial being conducted?
This trial is being conducted at Bolzano, Italy.
Who is sponsoring the NCT06370689 clinical trial?
NCT06370689 is sponsored by Institute of Mountain Emergency Medicine. The principal investigator is Simon Rauch, MD, PhD at Institute of Mountain Emergency Medicine, Eurac Research. The trial plans to enroll 45 participants.