RECRUITING

Providing Oxygen During Intubation in the NICU Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU

Quick Facts

Study Start:2022-07-21
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05451953

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.

Ages Eligible for Study:0 Days to 365 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Infants ≥28 weeks corrected gestational age
  2. 2. Undergoing intubation in the NICU
  3. 3. Pre-medication (including paralytic) administered
  1. 1. Critical Airway or Airway Anomaly
  2. 2. Unstable hemodynamics (i.e. active resuscitation)
  3. 3. Unable to achieve SpO2 ≥90% prior to intubation attempt
  4. 4. Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
  5. 5. Unrepaired congenital diagrammatic hernia
  6. 6. Tracheal esophageal fistula within 2 weeks of repair
  7. 7. Tracheostomy
  8. 8. Previous enrollment in the trial
  9. 9. Nasal intubation
  10. 10. COVID person under investigation (PUI) or COVID positive
  11. 11. Cyanotic heart disease
  12. 12. Receiving Extracorporeal Membrane Oxygenation support
  13. 13. Conjoined twins

Contacts and Locations

Study Contact

Heidi Herrick, MD, MSCE
CONTACT
267-408-6146
herrickh@chop.edu
Elizabeth Foglia, MD, MSCE
CONTACT
267-441-7144
foglia@chop.edu

Principal Investigator

Elizabeth Foglia, MD, MSCE
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-21
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2022-07-21
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • Apneic Oxygenation
  • Tracheal Intubation
  • Neonate

Additional Relevant MeSH Terms

  • Neonatal Respiratory Failure
  • Tracheal Intubation Morbidity