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SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation

NCT06683599 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-08-25

No results posted yet for this study

Summary

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

  • Difficult Airway
  • Difficult Airway Intubation
  • Neonate

Interventions

PROCEDURE

Apneic oxygenation

1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1.

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER

  • The University of Western Australia

    collaborator OTHER

  • Vinícius C Quintão, MD, MSc, PhD

    lead OTHER

Principal Investigators

  • Vinicius C Quintao, MD, MSc, PhD · Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
52 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2027-06-01
Completion
2027-12-01

Countries

  • Australia
  • Brazil
  • Canada
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683599 on ClinicalTrials.gov