NCT05451953

Providing Oxygen During Intubation in the NICU Trial

Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 0 Days – 365 Days
• Healthy volunteers: Not accepted

Summary

Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.

Conditions

• Neonatal Respiratory Failure
• Tracheal Intubation Morbidity

Interventions

Type	Name	Description
PROCEDURE	Apneic Oxygenation	Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)
PROCEDURE	Standard of Care	No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)

Timeline

• Start date: 2022-07-20
• Primary completion: 2026-12-31
• Completion: 2027-02-28
• First posted: 2022-07-11
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States