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NCT Number: NCT06370689

Comparison of Three Pre-oxygenation Strategies

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.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TerraXCube

Bolzano, Italy

Location status: Recruiting

Location contact

Simon Rauch

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoxygenation

Other

Preoxygenation of volunteers over 3 minutes

Primary outcomes

  1. Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.

    Time frame: 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 outcomes

  1. Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions.

    Time frame: 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).

  2. 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

    Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)

  3. 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) ≥ 0.5

  4. Time to reaching an Oxygen Reserve Index (ORi) =1

    Time frame: Variable, timepoint during the 3 min preoxygenation session

    Time to reaching an Oxygen Reserve Index (ORi) =1

  5. 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.

    Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Roveri, MD

CONTACT

[email protected]

Simon Rauch, MD, PhD

CONTACT

[email protected]

00393404967398

Sponsors and collaborators

Lead sponsor

Institute of Mountain Emergency Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 17, 2024
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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