RecruitingNot ApplicableNCT05451953

Providing Oxygen During Intubation in the NICU Trial

Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU


Sponsor

University of Pennsylvania

Enrollment

110 participants

Start Date

Jul 20, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 DaysMax Age: 365 Days

Inclusion Criteria3

  • Infants ≥28 weeks corrected gestational age
  • Undergoing intubation in the NICU
  • Pre-medication (including paralytic) administered

Exclusion Criteria13

  • 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

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Interventions

PROCEDUREApneic Oxygenation

Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)

PROCEDUREStandard of Care

No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)


Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT05451953


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