EmergenciesNCT06370689
Comparison of Three Pre-oxygenation Strategies
A study testing Preoxygenation in people with Emergencies and Anesthesia, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergencies, Anesthesia
- What is being tested?
- Preoxygenation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giulia Roveri, MD contact
Italy1 site, 1 recruiting
- Recruiting
TerraXCube
Bolzano
Simon Rauch, simon.rauch@eurac.edu
About this study
Official title: Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults
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
Read more
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
- Being tested
- Preoxygenation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreoxygenationOther
Preoxygenation of volunteers over 3 minutes
| Study group | Role | What they receive |
|---|---|---|
| NRM - Non-rebreather mask in children 6-12 yrs | Active comparator | Non-rebreather mask in children 6-12 yrs Receives: 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 Receives: 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 Receives: Other: Preoxygenation |
| NRM - Non-rebreather mask in normal weight adults | Active comparator | Non-rebreather mask in normal weight adults Receives: Other: Preoxygenation |
| BVM with PEEP in normal weight adults | Active comparator | Bag valve mask with positive end-expiratory pressure (PEEP) in normal weight adults Receives: Other: Preoxygenation |
| BVM without PEEP in normal weight adults | Active comparator | Bag valve mask without positive end-expiratory pressure (PEEP) in normal weight adults Receives: Other: Preoxygenation |
| NRM - Non-rebreather mask in overweight/obese adults | Active comparator | Non-rebreather mask in overweight/obese adults Receives: Other: Preoxygenation |
| BVM with PEEP in overweight/obese adults | Active comparator | Bag valve mask with positive end-expiratory pressure (PEEP) in overweight/obese adults Receives: Other: Preoxygenation |
| BVM without PEEP in overweight/obese adults | Active comparator | Bag valve mask without positive end-expiratory pressure (PEEP) in overweight/obese adults Receives: Other: Preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3 minutes of preoxygenation
Secondary outcomes (5)
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).
Measured: 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)
Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)
Measured: After 1.5 and 3 minutes of preoxygenation
Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5
Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5
Measured: Variable, timepoint during the 3 min preoxygenation session
Time to reaching an Oxygen Reserve Index (ORi) =1
Time to reaching an Oxygen Reserve Index (ORi) =1
Measured: Variable, timepoint during the 3 min preoxygenation session
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.
Measured: Washout phase after the 3 min preoxygenation sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start23 May 2024
- Primary completion31 Dec 2024
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Rauch, MD, PhD, Principal investigator, Institute of Mountain Emergency Medicine, Eurac Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370689
- Sponsor's protocol ID
- PRE-OX
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40392551
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults
- ClinicalTrials.gov ID
- NCT06370689
- Acronym / sponsor ID
- PRE-OX
- Conditions
- Emergencies, Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| NRM - Non-rebreather mask in children 6-12 yrs | Active comparator | Other: PreoxygenationNon-rebreather mask in children 6-12 yrs |
| BVM with PEEP in children 6-12 yrs | Active comparator | Other: PreoxygenationBag valve mask with positive end-expiratory pressure (PEEP) in children 6-12 yrs |
| BVM without PEEP in children 6-12 yrs | Active comparator | Other: PreoxygenationBag valve mask without positive end-expiratory pressure (PEEP) in children 6-12 yrs |
| NRM - Non-rebreather mask in normal weight adults | Active comparator | Other: PreoxygenationNon-rebreather mask in normal weight adults |
| BVM with PEEP in normal weight adults | Active comparator | Other: PreoxygenationBag valve mask with positive end-expiratory pressure (PEEP) in normal weight adults |
| BVM without PEEP in normal weight adults | Active comparator | Other: PreoxygenationBag valve mask without positive end-expiratory pressure (PEEP) in normal weight adults |
| NRM - Non-rebreather mask in overweight/obese adults | Active comparator | Other: PreoxygenationNon-rebreather mask in overweight/obese adults |
| BVM with PEEP in overweight/obese adults | Active comparator | Other: PreoxygenationBag valve mask with positive end-expiratory pressure (PEEP) in overweight/obese adults |
| BVM without PEEP in overweight/obese adults | Active comparator | Other: PreoxygenationBag valve mask without positive end-expiratory pressure (PEEP) in overweight/obese adults |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreoxygenationPreoxygenation of volunteers over 3 minutes | Other | 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 |
Primary outcome
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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 40392551Roveri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giulia Roveri, MD contact
Simon Rauch, MD, PhD principal investigator
Institute of Mountain Emergency Medicine, Eurac Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoxygenation in people with Emergencies and Anesthesia, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Rauch, MD, PhD (00393404967398, simon.rauch@eurac.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions. (time frame: After 3 minutes of preoxygenation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06370689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.