NCT06370689

Comparison of Three Pre-oxygenation Strategies

Recruiting now NA Last updated 28 March 2025

What this trial tests

NA trial testing Preoxygenation in Emergencies in 45 participants. Currently enrolling.

Timeline

23 May 2024

Primary endpoint
31 December 2024

30 July 2025

Quick facts

Lead sponsor	Institute of Mountain Emergency Medicine
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	45
Start date	23 May 2024
Primary completion	31 December 2024
Estimated completion	30 July 2025
Sites	1 location across Italy

Drugs / interventions tested

• Preoxygenation

Conditions studied

• Emergencies — all drugs for Emergencies →
• Anesthesia — all drugs for Anesthesia →

Sponsor

Institute of Mountain Emergency Medicine

Who can join

6 and older, any sex, with Emergencies or Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Preoxygenation With and Without Positive End-Expiratory Pressure in Lung-Healthy Volunteers: A Randomized Clinical Trial.
   Roveri G, Camporesi A, Hofer A, Kahlen S, et al · · 2025 · cited 3× · PMID 40392551 · DOI 10.1001/jamanetworkopen.2025.11569