Providing Oxygen During Intubation in the NICU Trial

Description

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

Study Overview

Study Details

Study overview

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.

Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU

Providing Oxygen During Intubation in the NICU Trial

Condition
Neonatal Respiratory Failure
Intervention / Treatment

-

Contacts and Locations

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Infants ≥28 weeks corrected gestational age
  • 2. Undergoing intubation in the NICU
  • 3. Pre-medication (including paralytic) administered
  • 1. Critical Airway or Airway Anomaly
  • 2. Unstable hemodynamics (i.e. active resuscitation)
  • 3. Unable to achieve SpO2 ≥90% prior to intubation attempt
  • 4. Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
  • 5. Unrepaired congenital diagrammatic hernia
  • 6. Tracheal esophageal fistula within 2 weeks of repair
  • 7. Tracheostomy
  • 8. Previous enrollment in the trial
  • 9. Nasal intubation
  • 10. COVID person under investigation (PUI) or COVID positive
  • 11. Cyanotic heart disease
  • 12. Receiving Extracorporeal Membrane Oxygenation support
  • 13. Conjoined twins

Ages Eligible for Study

0 Days to 365 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Elizabeth Foglia, MD, MSCE, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2025-01-31