Comparison of Three Pre-oxygenation Strategies

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06370689
Study type	Interventional
Source	Institute of Mountain Emergency Medicine
Contact	Simon Rauch, MD, PhD
Phone	00393404967398
Email	simon.rauch@eurac.edu
Status	Not yet recruiting
Phase	N/A
Start date	May 23, 2024
Completion date	July 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04580030` - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting	`NCT04279054` - Decreased Neuraxial Morphine After Cesarean Delivery	Early Phase 1
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Recruiting	`NCT04099693` - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated	`NCT02481999` - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed	`NCT04235894` - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting	`NCT05525104` - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).	N/A
Recruiting	`NCT05024084` - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth	Phase 4
Completed	`NCT04204785` - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions	N/A
Completed	`NCT03277872` - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope	N/A
Terminated	`NCT03940651` - Cardiac and Renal Biomarkers in Arthroplasty Surgery	Phase 4
Terminated	`NCT02529696` - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Terminated	`NCT03704285` - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting	`NCT05259787` - EP Intravenous Anesthesia in Hysteroscopy	Phase 4
Completed	`NCT02894996` - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?	N/A
Completed	`NCT05386082` - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated	`NCT03567928` - Laryngeal Mask in Upper Gastrointestinal Procedures	N/A
Recruiting	`NCT06074471` - Motor Sparing Supraclavicular Block	N/A
Completed	`NCT04163848` - CARbon Impact of aNesthesic Gas

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.