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NCT06683599: SEALION

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

Recruiting now NA Last updated 25 November 2025
What this trial tests

NA trial testing Apneic oxygenation in Difficult Airway in 240 participants. Currently enrolling.

Timeline
10 December 2024
Primary endpoint
1 June 2026
1 December 2026

Quick facts

Lead sponsorVinícius C Quintão, MD, MSc, PhD
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment240
Start date10 December 2024
Primary completion1 June 2026
Estimated completion1 December 2026
Sites3 locations across Sweden, Australia, Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Vinícius C Quintão, MD, MSc, PhD

Who can join

Adults 1 Minute to 52 Weeks, any sex, with Difficult Airway or Difficult Airway Intubation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Apneic oxygenation

Trials testing the same drug.

Other recruiting trials for Difficult Airway

Currently open trials in the same condition.

Other Vinícius C Quintão, MD, MSc, PhD trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06683599.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing