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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 1
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Perth Children's Hospital
RECRUITING
Perth
Brazil
Hospital das Clinicas HCFMUSP
RECRUITING
São Paulo
Denmark
University of Copenhagen
NOT_YET_RECRUITING
Copenhagen
Sweden
Uppsala University Hospital
NOT_YET_RECRUITING
Uppsala
Contact Information
Primary
Vinicius C Quintao, MD, MSc, PhD
vinicius.quintao@hc.fm.usp.br
+ 55 11 97127-3950
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 240
Treatments
No_intervention: Standard of care
Tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1 without apneic oxygenation.
Experimental: 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: The University of Western Australia, University of Bern
Leads: Vinícius C Quintão, MD, MSc, PhD

This content was sourced from clinicaltrials.gov