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Apnoeic Oxygenation During Pediatric Tracheal Intubation

RecruitingNAAges 0 Years - 6 YearsAllUniversity Hospital Heidelberg
NCT06576596 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 independ

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📋 Eligibility rules (as published)
Inclusion Criteria: * children 0-6 years * ASA status I-III * Elective surgery/intervention under general anaesthesia Exclusion Criteria: * refusal to participate in the study by the patients or their legal guardians * ASA classification IV = patients with life-threatening disease * Existing oxygen therapy prior to surgery * Surgery/intervention in the ENT area with contraindication for oxygen goggles * Injuries/trauma in the ENT and mouth/nose area * Anatomical anomalies/malformations in the ENT and mouth/nose area * Chronical hypoxemia (e.g. patients with cyanotic heart diseases) * language barrier (parent/guardian) * emergency interventions * refusal by the attending physician * lack of presence of the pediatric anesthesiology consultant * Situational inability to perform apnoeic oxygenation or inability to obtain baseline NIRS values at room air within 60 seconds from the first attempt due to agitation of the patient
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What it tests

  • apnoeic Oxygenation
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Where

1 site
Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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