Apnoeic Oxygenation During Pediatric Tracheal Intubation

Recruiting now · Not applicable

Conditions studied: Anesthesia, Airway Complication of Anesthesia, Anesthesia; Adverse Effect

In brief

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 primary and secondary endpoints will be conducted independently for each cohort. This stratified approach will allow for targeted evaluation of age-specific effects of the intervention, as well as comparison between intervention and control outcomes within each age-defined cohort.

Key facts

Study ID

NCT06576596

Run by

University Hospital Heidelberg

People needed

200

Starts

2024-09-09

Expected to finish

2025-08-31

Last updated by the study team

2025-03-03

Who can join

Age: any, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• children 0-6 years
• ASA status I-III
• Elective surgery/intervention under general anaesthesia

You may not qualify if…

• 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

Where it is running

• Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University, — Heidelberg, Baden-Wurttemberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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