Recruiting

Apneic Oxygenation

Sponsor:

Vinícius C Quintão, MD, MSc, PhD

Code:

NCT06683599

Conditions

Difficult Airway

Difficult Airway Intubation

Neonate

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Apneic oxygenation

Study Details

Brief 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

Study ID

NCT06683599

Start date

Dec 10, 2024

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.
  • Requirement for an alternative technique to direct laryngoscopy to secure the airway.
  • Specific conditions, such as congenital heart disease requiring FiO₂ < 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • First-attempt success rate [ Time Frame: From randomization until up to 15 minutes ]

Central Contacts and Locations

Central contacts

Vinicius C Quintao, MD, MSc, PhD

+ 55 11 97127-3950vinicius.quintao@hc.fm.usp.br

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

More Information

Sponsor

Vinícius C Quintão, MD, MSc, PhD

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Difficult intubation
  • Apneic oxygenation
  • Neonate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vinícius C Quintão, MD, MSc, PhD on 2026-08-25.