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RECRUITING
NCT06683599
NA

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

Sponsor: Vinícius C Quintão, MD, MSc, PhD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Minute - 52 Weeks

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-12-10

Completion Date

2026-12-01

Last Updated

2025-11-25

Healthy Volunteers

No

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.

Locations (3)

Perth Children's Hospital

Perth, Western Australia, Australia

Hospital das Clinicas HCFMUSP

São Paulo, Brazil

Uppsala University Hospital

Uppsala, Sweden