RecruitingNot ApplicableNCT06370689

Comparison of Three Pre-oxygenation Strategies

Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults


Sponsor

Institute of Mountain Emergency Medicine

Enrollment

45 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study compares three methods of pre-oxygenation — the process of loading oxygen into the lungs before anesthesia — to determine which approach is most effective at raising and maintaining oxygen levels: a non-rebreather face mask, a bag-valve-mask without pressure, or a bag-valve-mask with added positive end-expiratory pressure (PEEP). Researchers use special oxygen sensors and lung imaging technology to measure ventilation changes in real time. Eligible participants include healthy normal-weight adults, overweight adults (BMI 25–40) with mild to moderate health status, and healthy children aged 6–12. Participation involves three 3-minute breathing sessions with the different oxygen delivery devices in a randomized order, with washout periods between sessions — no anesthesia or procedures are involved. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPreoxygenation

Preoxygenation of volunteers over 3 minutes


Locations(1)

TerraXCube

Bolzano, Italy

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NCT06370689


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