Providing Oxygen During Intubation in the NICU Trial

NCT05451953 | Recruiting DMC

• 2 other identifiers: 19-017190R21HD103927
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Apneic Oxygenation; Tracheal Intubation; Neonate

Outcome Measures

Primary Outcomes (1)

• Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)

  Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter.

  During intubation procedure

Secondary Outcomes (15)

• Secondary Clinical Outcome: Severe oxygen desaturation

  During intubation procedure

• Secondary Clinical Outcome: SpO2<80%

  During intubation procedure

• Secondary Clinical Outcome: Time to SpO2 <80%

  During intubation procedure

• Secondary Clinical Outcome: intubation success

  During intubation procedure

• Secondary Clinical Outcome: Number of intubation attempts

  During intubation procedure

Other Outcomes (5)

• Safety Outcome: Cardiopulmonary resuscitation

  During or within 1 hour of procedure

• Safety Outcome: Air Leaks

  Within 24 hours of procedure

• Safety Outcome: Nasal Trauma

  Within 24 hours of procedure

Study Arms (2)

Apneic Oxygenation

EXPERIMENTAL

Procedure: Apneic Oxygenation

Standard of Care

ACTIVE COMPARATOR

Procedure: Standard of Care

Interventions

Apneic Oxygenation PROCEDURE

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

Apneic Oxygenation

Standard of Care PROCEDURE

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

Standard of Care

Eligibility Criteria

• Age: 0 Days - 365 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (36)

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MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elizabeth Foglia, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi Herrick, MD, MSCE

CONTACT

267-408-6146; herrickh@chop.edu

Elizabeth Foglia, MD, MSCE

CONTACT

267-441-7144; foglia@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Parallel group open-label randomized controlled trial.

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: July 11, 2022
• Study Start: July 20, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After study completion.
• Access Criteria: Data use agreement in place prior to data sharing.

Locations

US (1)