Using apnoeic oxygenation to improve pediatric tracheal intubation outcomes
Apnoeic Oxygenation During Pediatric Tracheal Intubation: a Study Protocol for a Single-center, Cluster Randomized Clinical Trial (ApOx-Pedi-Trial)
This study is testing if using extra oxygen during tracheal intubation can help improve outcomes for children having anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 0 Years to 6 Years |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Locations | 1 site (Heidelberg, Baden-Wurttemberg) |
| Trial ID | NCT06576596 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-6 years undergoing elective surgery under general anesthesia with ASA status I-III.
Not a fit: Patients with life-threatening diseases, existing oxygen therapy, or those undergoing emergency interventions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Heidelberg, Baden-Wurttemberg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.