Using apnoeic oxygenation to improve pediatric tracheal intubation outcomes
Official title: Apnoeic Oxygenation During Pediatric Tracheal Intubation: a Study Protocol for a Single-center, Cluster Randomized Clinical Trial (ApOx-Pedi-Trial)
Run by University Hospital Heidelberg · NCT06576596 · Data updated 2026-11-12
This study is testing if using extra oxygen during tracheal intubation can help improve outcomes for children having anesthesia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Years to 6 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital Heidelberg Academic / other |
| Locations | 1 site (Heidelberg, Baden-Wurttemberg) |
| Status | Recruiting |
| Started | September 9, 2024 |
| Main results expected | April 30, 2025 |
| Study ends | August 31, 2025 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT06576596 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 0-6 years undergoing elective surgery under general anesthesia with ASA status I-III.
✕Probably not a fit
Patients with life-threatening diseases, existing oxygen therapy, or those undergoing emergency interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of apnoeic oxygenation during tracheal intubation in pediatric patients. It involves a randomized, controlled, single-blinded design where participants are divided into two age-dependent groups: one receiving apnoeic oxygenation and the other serving as a control. The primary outcome is the lowest recorded SpO₂ value during the apnoeic period, while secondary outcomes include intubation success rates, time to desaturation, and incidence of anesthesia-related adverse events. The study aims to enhance airway management and reduce hypoxia-related complications in children undergoing anesthesia.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of hypoxia and related complications during pediatric anesthesia.
How similar studies have gone: While apnoeic oxygenation is increasingly becoming a standard technique in pediatric anesthesia, this specific study's approach is novel and aims to provide further evidence of its effectiveness.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
Heidelberg, Baden-Wurttemberg, Germany Recruiting
Study contacts
- Study coordinator: Davut Deniz Uzun, Dr. /MD
- Email: deniz.uzun@med.uni-heidelberg.de
- Phone: +49 62215639349
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.