Providing Oxygen During Intubation in the NICU Trial
Completed · Not applicable
Conditions studied: Neonatal Respiratory Failure, Tracheal Intubation Morbidity
In brief
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.
Key facts
- Study ID
- NCT05451953
- Run by
- University of Pennsylvania
- People needed
- 110
- Starts
- 2022-07-20
- Expected to finish
- 2026-06-03
- Last updated by the study team
- 2026-06-11
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants ≥28 weeks corrected gestational age
- Undergoing intubation in the NICU
- Pre-medication (including paralytic) administered
You may not qualify if…
- Critical Airway or Airway Anomaly
- Unstable hemodynamics (i.e. active resuscitation)
- Unable to achieve SpO2 ≥90% prior to intubation attempt
- Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
- Unrepaired congenital diagrammatic hernia
- Tracheal esophageal fistula within 2 weeks of repair
- Tracheostomy
- Previous enrollment in the trial
- Nasal intubation
- COVID person under investigation (PUI) or COVID positive
- Cyanotic heart disease
- Receiving Extracorporeal Membrane Oxygenation support
- Conjoined twins
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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