Preoxygenation With and Without Positive End-Expiratory Pressure in Lung-Healthy Volunteers: A Randomized Clinical Trial.
Giulia Roveri, Anna Camporesi, Alex Hofer...
https://pubmed.ncbi.nlm.nih.gov/40392551Actively Recruiting
Phase Not Applicable
Age: 6Years +
All Genders
Healthy Volunteers
ID06370689
Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults
Led by Institute of Mountain Emergency Medicine · Updated on 2025-03-28
45
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of three different methods of preoxygenation in volunteers who are breathing on their own. The study focuses on children aged 6 to 12 years who are healthy, normal-weight adults with a specific health status, and overweight or obese adults with certain health criteria. The goal is to compare how well each method increases oxygen levels before anesthesia, using specific measures such as expiratory oxygen concentration and Oxygen Reserve Index. Participants will undergo three preoxygenation sessions using different devices: a non-rebreather face mask, a bag-valve-mask with positive end-expiratory pressure (PEEP), and a bag-valve-mask without PEEP. These sessions will be done in random order with 20-minute breaks between them. Each session lasts up to 3 minutes or until a target oxygen level is reached. The study groups include children, normal-weight adults, and overweight or obese adults, each receiving all three preoxygenation methods. During the study, participants will have baseline measurements taken for oxygen saturation, Oxygen Reserve Index, and lung ventilation for 10 minutes. After each preoxygenation session, these measurements will be repeated and monitored for 10 minutes. Researchers will assess changes in oxygen levels, ventilation, and the time taken to reach specific oxygen reserve thresholds. The total participation includes multiple sessions with monitoring before, during, and after each preoxygenation method.
CONDITIONS
Brief Title
Comparison of Three Pre-oxygenation Strategies
Who Can Participate
Age: 6Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Normal-weight adults with a body mass index (BMI) of 18.5 to 24.9 kg/m2 and an ASA physical status of I or II
- Adults with a BMI of 25 to 39.9 kg/m2 and an ASA score less than 3
- Healthy children aged 6 to 12 years with an ASA physical status of I
You will not qualify if you...
- ASA physical status of 3 or higher
- Age younger than 6 years or between 12 and 18 years
- Pregnant women
- Missing informed consent
- Signs or symptoms of an acute respiratory illness on the study day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single session with multiple preoxygenation periods
Participants undergo three different preoxygenation strategies, each lasting 3 minutes, to compare their effectiveness.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
TerraXCube
Bolzano, Italy
Actively Recruiting
Loading map...
Research Team
S
Simon Rauch, MD, PhD
G
Giulia Roveri, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
9
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here