Condition: Anesthesia · Airway Complication of Anesthesia · Anesthesia; Adverse Effect · Sponsor: University Hospital Heidelberg
The goal of this randomized, controlled, single-blinded clinical trial is to evaluate the effectiveness of apnoeic Oxygenation in pediatric anesthesia. The main question it aims to answer are: primary outcome measure: The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period. secondary outcome measure: * Differences in intubation first-pass-success (key secondary objective) * Temporal differences to achieve successful intubation * Differences in time to oxygen desaturation * Differences in heart rate and mean arterial blood pressure decrease * Differences in the incidence of anesthesia-related adverse events The study participants are randomized two age dependents groups. Either in the control group without the use of apnoeic oxygenation or in the intervention group with the use of apnoeic oxygenation. The study population will be divided into two independent cohorts, each consisting of 100 patients. The first cohort, designated as "infants" will include all patients aged up to 24 months, while the second cohort, termed "children" will comprise patients aged older than 24 months and up to six years. Within each cohort, patients will be randomized into an intervention group and a control group, with 50 patients assigned to each. This randomization will ensure that, for both the Infant and Children Groups, half of the participants (n=50) will receive the intervention, while the other half (n=50) will serve as controls. Statistical analysis of p…
This description comes directly from the study's public registry record.
Davut Deniz Uzun, Dr. /MD · +49 62215639349 · deniz.uzun@med.uni-heidelberg.de
Felix Schmitt, Assoc. Professor. · +49 6221-56 394 21 · Felix.Schmitt@med.uni-heidelberg.de
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| Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University, | Heidelberg, Baden-Wurttemberg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06576596