Comparison of Three Pre-oxygenation Strategies

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370689
• Other study ID #: PRE-OX
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: April 2024
• Source: Institute of Mountain Emergency Medicine
• Contact: Simon Rauch, MD, PhD
• Phone: 00393404967398
• Email: simon.rauch[@]eurac.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Emergencies

Intervention

Other:
• Preoxygenation
Preoxygenation of volunteers over 3 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Mountain Emergency Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.	Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions between the three arms.	After 3 minutes of preoxygenation
Secondary	Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions.	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).	After 3 minutes of preoxygenation
Secondary	Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)	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
Secondary	Time to reaching an Oxygen Reserve Index (ORi) = 0.5	Time to reaching an Oxygen Reserve Index (ORi) = 0.5	Variable, timepoint during the 3 min preoxygenation session
Secondary	Time to reaching an Oxygen Reserve Index (ORi) =1	Time to reaching an Oxygen Reserve Index (ORi) =1	Variable, timepoint during the 3 min preoxygenation session
Secondary	Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.	Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.	Washout phase after the 3 min preoxygenation sessions.