Supplemental oxygenation for young children during intubation
SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula
This study tests if giving extra oxygen through a small tube in the nose can help young children breathe better during intubation and make the process safer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 1 Minute to 52 Weeks |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 3 sites (Perth, Western Australia and 2 other locations) |
| Trial ID | NCT06683599 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of supplemental oxygen via nasal cannula during the intubation process in neonates and infants. It aims to improve the safety and success rate of tracheal intubation by extending the safe apnea time and reducing the risk of desaturation. Eligible participants will undergo standard anesthesia induction procedures, followed by pre-oxygenation and apneic oxygenation techniques. The study will monitor vital signs to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates include neonates and infants up to 52 weeks post-conceptual age requiring intubation for various procedures.
Not a fit: Patients predicted to have difficult intubation or those requiring alternative airway management techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risks associated with intubation in neonates, leading to improved patient outcomes.
How similar studies have performed: Previous studies have indicated that low-flow oxygen supplementation can extend safe apnea time, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures. * Neonates and infants up to 52 weeks post-conceptual age. * Written informed consent provided by legal guardians prior to the intervention. Exclusion Criteria: * Prediction of difficult intubation based on physical examination or a history of previous difficult intubation. * Requirement for an alternative technique to direct laryngoscopy to secure the airway. * Specific conditions, such as congenital heart disease requiring FiO₂ \< 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.
Where this trial is running
Perth, Western Australia and 2 other locations
- Perth Children's Hospital — Perth, Western Australia, Australia (Recruiting)
- Hospital das Clinicas HCFMUSP — São Paulo, Brazil (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Vinicius C Quintao, MD, MSc, PhD — Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
- Study coordinator: Vinicius C Quintao, MD, MSc, PhD
- Email: vinicius.quintao@hc.fm.usp.br
- Phone: + 55 11 97127-3950
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.