Comparison of Three Pre-oxygenation Strategies

NCT06370689 | Recruiting

• 1 other identifier: PRE-OX
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  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)

  After 1.5 and 3 minutes of preoxygenation

• Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5

  Variable, timepoint during the 3 min preoxygenation session

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

  Variable, timepoint during the 3 min preoxygenation session

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

  Washout phase after the 3 min preoxygenation sessions.

Study Arms (9)

NRM - Non-rebreather mask in children 6-12 yrs

ACTIVE COMPARATOR

Non-rebreather mask in children 6-12 yrs

Other: Preoxygenation

BVM with PEEP in children 6-12 yrs

ACTIVE COMPARATOR

Bag valve mask with positive end-expiratory pressure (PEEP) in children 6-12 yrs

Other: Preoxygenation

BVM without PEEP in children 6-12 yrs

ACTIVE COMPARATOR

Bag valve mask without positive end-expiratory pressure (PEEP) in children 6-12 yrs

Other: Preoxygenation

NRM - Non-rebreather mask in normal weight adults

ACTIVE COMPARATOR

Non-rebreather mask in normal weight adults

Other: Preoxygenation

BVM with PEEP in normal weight adults

ACTIVE COMPARATOR

Bag valve mask with positive end-expiratory pressure (PEEP) in normal weight adults

Other: Preoxygenation

BVM without PEEP in normal weight adults

ACTIVE COMPARATOR

Bag valve mask without positive end-expiratory pressure (PEEP) in normal weight adults

Other: Preoxygenation

NRM - Non-rebreather mask in overweight/obese adults

ACTIVE COMPARATOR

Non-rebreather mask in overweight/obese adults

Other: Preoxygenation

BVM with PEEP in overweight/obese adults

ACTIVE COMPARATOR

Bag valve mask with positive end-expiratory pressure (PEEP) in overweight/obese adults

Other: Preoxygenation

BVM without PEEP in overweight/obese adults

ACTIVE COMPARATOR

Bag valve mask without positive end-expiratory pressure (PEEP) in overweight/obese adults

Other: Preoxygenation

Interventions

Preoxygenation OTHER

Preoxygenation of volunteers over 3 minutes

BVM with PEEP in children 6-12 yrs; BVM with PEEP in normal weight adults; BVM with PEEP in overweight/obese adults; BVM without PEEP in children 6-12 yrs; BVM without PEEP in normal weight adults; BVM without PEEP in overweight/obese adults; NRM - Non-rebreather mask in children 6-12 yrs; NRM - Non-rebreather mask in normal weight adults; NRM - Non-rebreather mask in overweight/obese adults

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Mountain Emergency Medicine: lead

Study Sites (1)

TerraXCube

Bolzano, Italy

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Rauch, MD, PhD

  Institute of Mountain Emergency Medicine, Eurac Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Rauch, MD, PhD

CONTACT

00393404967398; simon.rauch@eurac.edu

Giulia Roveri, MD

CONTACT

giulia.roveri@eurac.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: May 23, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)