Actively Recruiting

Phase Not Applicable
Age: 1Minute - 52Weeks
All Genders
NCT06683599

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

Age: 1Minute - 52Weeks
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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