Comparing three methods of pre-oxygenation
Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults
This study is testing which of three different ways to provide oxygen works best for people breathing on their own before medical procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Institute of Mountain Emergency Medicine Academic / other |
| Locations | 1 site (Bolzano) |
| Trial ID | NCT06370689 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of three different pre-oxygenation strategies: using a non-rebreather face mask, a bag-valve-mask with positive end-expiratory pressure, and a bag-valve-mask without additional pressure. The study involves spontaneously breathing volunteers and aims to measure various endpoints, including expiratory oxygen concentration and Oxygen Reserve Index at different time points during the pre-oxygenation sessions. A total of 45 participants will be enrolled, divided into three subgroups, to assess the differences in oxygenation strategies.
Who should consider this trial
Good fit: Ideal candidates include normal-weight adults and healthy children aged 6-12 years who meet specific ASA classification criteria.
Not a fit: Patients with ASA classification of 3 or those with acute respiratory illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize pre-oxygenation techniques, improving patient outcomes during anesthesia and emergency situations.
How similar studies have performed: While the specific approaches may be novel, similar studies have explored pre-oxygenation strategies, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bolzano
- TerraXCube — Bolzano, Italy (Recruiting)
Study contacts
- Principal investigator: Simon Rauch, MD, PhD — Institute of Mountain Emergency Medicine, Eurac Research
- Study coordinator: Simon Rauch, MD, PhD
- Email: simon.rauch@eurac.edu
- Phone: 00393404967398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.