Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)