Clinical trial NCT06370689: Comparison of Three Pre-oxygenation Strategies
Official title: Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergencies
Anesthesia
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Primary outcomes:
measure: Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.
timeFrame: After 3 minutes of preoxygenation
Secondary outcomes:
measure: Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions.
timeFrame: After 3 minutes of preoxygenation
measure: Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)
timeFrame: After 1.5 and 3 minutes of preoxygenation
measure: Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5
timeFrame: Variable, timepoint during the 3 min preoxygenation session
measure: Time to reaching an Oxygen Reserve Index (ORi) =1
timeFrame: Variable, timepoint during the 3 min preoxygenation session
measure: Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.
timeFrame: Washout phase after the 3 min preoxygenation sessions.
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: TerraXCube
Study officials:
affiliation: Institute of Mountain Emergency Medicine, Eurac Research
name: Simon Rauch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: