Comparison of Three Pre-oxygenation Strategies
- Conditions
- EmergenciesAnesthesia
- Interventions
- Other: Preoxygenation
- Registration Number
- NCT06370689
- Lead Sponsor
- Institute of Mountain Emergency Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BVM with PEEP in children 6-12 yrs Preoxygenation Bag valve mask with positive end-expiratory pressure (PEEP) in children 6-12 yrs BVM without PEEP in overweight/obese adults Preoxygenation Bag valve mask without positive end-expiratory pressure (PEEP) in overweight/obese adults BVM without PEEP in normal weight adults Preoxygenation Bag valve mask without positive end-expiratory pressure (PEEP) in normal weight adults BVM with PEEP in overweight/obese adults Preoxygenation Bag valve mask with positive end-expiratory pressure (PEEP) in overweight/obese adults BVM with PEEP in normal weight adults Preoxygenation Bag valve mask with positive end-expiratory pressure (PEEP) in normal weight adults BVM without PEEP in children 6-12 yrs Preoxygenation Bag valve mask without positive end-expiratory pressure (PEEP) in children 6-12 yrs NRM - Non-rebreather mask in normal weight adults Preoxygenation Non-rebreather mask in normal weight adults NRM - Non-rebreather mask in children 6-12 yrs Preoxygenation Non-rebreather mask in children 6-12 yrs NRM - Non-rebreather mask in overweight/obese adults Preoxygenation Non-rebreather mask in overweight/obese adults
- Primary Outcome Measures
Name Time Method Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions. 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 Outcome Measures
Name Time Method Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions. Washout phase after the 3 min preoxygenation sessions. Time to Oxygen Reserve Index (ORi) back to baseline 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 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) =1 Variable, timepoint during the 3 min preoxygenation session Time to reaching an Oxygen Reserve Index (ORi) =1
Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. After 3 minutes of preoxygenation 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).
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) ≥ 0.5
Trial Locations
- Locations (1)
TerraXCube
🇮🇹Bolzano, Italy