Providing Oxygen During Intubation in the NICU Trial

Launched by UNIVERSITY OF PENNSYLVANIA · Jul 6, 2022

Keywords

ClinConnect Summary

The "Providing Oxygen During Intubation in the NICU Trial" is a clinical study that aims to improve the safety of a procedure called tracheal intubation in newborns experiencing breathing difficulties. During this procedure, babies often experience a drop in oxygen levels, which can be harmful. This trial is exploring whether giving oxygen through a small tube in the nose (called nasal cannula) can help keep oxygen levels stable during intubation, compared to standard care without extra oxygen. The study will take place at two hospitals: the Hospital of the University of Pennsylvania and the Children's Hospital of Philadelphia.

To participate in this trial, infants must be at least 28 weeks old (corrected gestational age) and are scheduled for intubation in the NICU. They also need to have received medication to help with the procedure. However, babies with certain medical conditions, such as airway problems or unstable heart rates, won't be eligible to join. If enrolled, participants will receive either the nasal oxygen or standard care during their intubation attempt. This study is currently recruiting participants, and it's an important step in finding ways to improve care for these vulnerable infants.

Gender

ALL

Eligibility criteria

• 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