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Recruiting NCT06370689

Comparison of Three Pre-oxygenation Strategies

No phase Interventional Emergencies Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoxygenation.
Who it may be relevant to
Registry conditions: Emergencies, Anesthesia. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Preoxygenation
    Preoxygenation of volunteers over 3 minutes

Primary outcome measures

  • Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions. [Time frame: After 3 minutes of preoxygenation]
Secondary outcome measures (5)
  • Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. [Time frame: After 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 frame: After 1.5 and 3 minutes of preoxygenation]
  • Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5 [Time frame: Variable, timepoint during the 3 min preoxygenation session]
  • Time to reaching an Oxygen Reserve Index (ORi) =1 [Time frame: Variable, timepoint during the 3 min preoxygenation session]
  • Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions. [Time frame: Washout phase after the 3 min preoxygenation sessions.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Italy · 1 center
  • TerraXCube — Bolzano

Publications

  • Roveri G, Camporesi A, Hofer A, Kahlen S, Breidt F, Rauch S. Preoxygenation With and Without Positive End-Expiratory Pressure in Lung-Healthy Volunteers: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511569. doi: 10.1001/jamanetworkopen.2025.11569. PMID 40392551

Identifiers

NCT: NCT06370689 · PRE-OX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗