Actively Recruiting
SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation
Led by Vinícius C Quintão, MD, MSc, PhD · Updated on 2025-11-25
240
Participants Needed
3
Research Sites
103 weeks
Total Duration
On this page
Sponsors
V
Vinícius C Quintão, MD, MSc, PhD
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \<80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L/kg/min) can extend safe apnea time. This study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.
CONDITIONS
Official Title
SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Predicted difficult intubation based on physical exam or history of previous difficult intubation.
- Need for alternative airway techniques other than direct laryngoscopy.
- Congenital heart disease requiring less than 100% oxygen (FiO2 < 1.0).
- Cardiopulmonary collapse requiring advanced life support and emergency intubation for surgical or non-surgical emergencies.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
2
Hospital das Clinicas HCFMUSP
São Paulo, Brazil, 05403000
Actively Recruiting
3
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
V
Vinicius C Quintao, MD, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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