TerraXCube
Bolzano, Italy
Location status: Recruiting
NCT Number: NCT06370689
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.
Interested in participating?
Request Info6 year and older
All sexes
Interventional
Not applicable
Bolzano, Italy
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoxygenation of volunteers over 3 minutes
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.
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).
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)
Time frame: Variable, timepoint during the 3 min preoxygenation session
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: Washout phase after the 3 min preoxygenation sessions.
Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.
Contact information is provided by the study sponsor or research team.
Giulia Roveri, MD
CONTACT
Simon Rauch, MD, PhD
CONTACT
Institute of Mountain Emergency Medicine
Other
Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children, Normal Weight Adults and Obese Adults
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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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