Providing Oxygen During Intubation in the NICU Trial (POINT)

University of Pennsylvania

Status: Enrolling

Conditions: Neonatal Respiratory Failure; Tracheal Intubation Morbidity

Treatments: Procedure: Apneic Oxygenation; Procedure: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05451953

R21HD103927 (U.S. NIH Grant/Contract)

19-017190

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: Under 365 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Apneic Oxygenation

Experimental group

Treatment:

Procedure: Apneic Oxygenation

Standard of Care

Active Comparator group

Treatment:

Procedure: Standard of Care