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Clinical Trials/NCT06370689
NCT06370689
Recruiting
Not Applicable

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

Institute of Mountain Emergency Medicine1 site in 1 country45 target enrollmentMay 23, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergencies
Sponsor
Institute of Mountain Emergency Medicine
Enrollment
45
Locations
1
Primary Endpoint
Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2024
End Date
July 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Institute of Mountain Emergency Medicine
Responsible Party
Sponsor

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

  • Age \< 6 and age 12-18
  • pregnant women
  • missing informed consent
  • signs and symptoms of an acute respiratory illness on the study day

Outcomes

Primary Outcomes

Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.

Time Frame: After 3 minutes of preoxygenation

Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions between the three arms.

Secondary Outcomes

  • Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.(Washout phase after 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)(After 1.5 and 3 minutes of preoxygenation)
  • Time to reaching an Oxygen Reserve Index (ORi) =1(Variable, timepoint during the 3 min preoxygenation session)
  • Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions.(After 3 minutes of preoxygenation)
  • Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5(Variable, timepoint during the 3 min preoxygenation session)

Study Sites (1)

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