Clinical trial Recruiting at 4 sites Interventional Ages 1 Minute to 52 Weeks

Supplemental oxygenation for young children during intubation

Official title: SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula

Run by University of Sao Paulo General Hospital · NCT06683599 · Data updated 2026-11-12

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

Study typeInterventional
Ages1 Minute to 52 Weeks
SexAll
Enrollment240 (estimated)
SponsorUniversity of Sao Paulo General Hospital
Academic / other
Locations4 sites (Perth, Western Australia and 3 other locations)
StatusRecruiting
StartedDecember 10, 2024
Main results expectedJune 1, 2027
Study endsDecember 1, 2027
Registry record updatedAugust 25, 2026
Trial IDNCT06683599 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include neonates and infants up to 52 weeks post-conceptual age requiring intubation for various procedures.

Probably not a fit

Patients predicted to have difficult intubation or those requiring alternative airway management techniques 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 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.

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 gone: Previous studies have indicated that low-flow oxygen supplementation can extend safe apnea time, suggesting potential success for this approach.

Who can join: the full rules

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 it's running

  • Perth Children's Hospital
    Perth, Western Australia, Australia
    Recruiting
  • Hospital das Clinicas HCFMUSP
    São Paulo, São Paulo, Brazil
    Recruiting
  • British Columbia Children's Hospital
    Vancouver, British Columbia, Canada
    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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.