Neonatal Respiratory Failure, Tracheal Intubation Morbidity
Conditions
Keywords
Apneic Oxygenation, Tracheal Intubation, Neonate
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.
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)
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital of Philadelphia
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel group open-label randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
0 Days to 365 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Clinical Outcome: Change in Oxygen Saturation (SpO2) | During intubation procedure | Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Clinical Outcome: Duration of intubation attempts | During intubation procedure | Duration of each intubation attempt |
| Feasibility Outcome: AO fidelity | During the intubation procedure | Proportion subjects allocated to AO successfully provided the AO intervention |
| Feasibility Outcome: Protocol deviations | During intubation procedure | Number of protocol deviations and violations |
| Feasibility Outcome: Screening | Through study completion, an average of 18 months. | Proportion of intubated infants successfully screened in advance |
| Feasibility Outcome: Recruitment | Through study completion, an average of 18 months. | Rates of informed consent |
| Feasibility Outcome: Randomization | Through study completion, an average of 18 months. | Proportion of consented infants who were randomized |
| Secondary Clinical Outcome: Severe oxygen desaturation | During intubation procedure | ≥20% decline in SpO2 |
| Secondary Clinical Outcome: SpO2<80% | During intubation procedure | SpO2\<80% at any point |
| Secondary Clinical Outcome: Time to SpO2 <80% | During intubation procedure | Time to SpO2 \<80% from facemask removal |
| Secondary Clinical Outcome: intubation success | During intubation procedure | First intubation attempt success |
| Secondary Clinical Outcome: Number of intubation attempts | During intubation procedure | Total number of intubation attempts |
| Secondary Clinical Outcome: Change in pulse rate | During intubation procedure | Difference between highest and lowest pulse rate |
| Secondary Clinical Outcome: pH | Three hours after intubation | First blood gas pH |
| Secondary Clinical Outcome: pCO2 | Three hours after intubation | First blood gas pCO2 |
| Secondary Clinical Outcome: PaO2 | Three hours after intubation | First blood gas PaO2 (for infants with indwelling arterial lines) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome: Nasal Trauma | Within 24 hours of procedure | New nasal trauma |
| Safety Outcome: adverse Tracheal Intubation Adverse Events | During Intubation Procedure | Tracheal Intubation Adverse Events, per NEAR4NEOS definitions |
| Safety Outcome: Duration of time with 100% SpO2 | During Intubation Procedure | Duration of time with SpO2=100% |
| Safety Outcome: Air Leaks | Within 24 hours of procedure | New pneumothorax |
| Safety Outcome: Cardiopulmonary resuscitation | During or within 1 hour of procedure | Chest compressions with or without epinephrine |
Countries
United States
Contacts
Primary ContactHeidi Herrick, MD, MSCE
Backup ContactElizabeth Foglia, MD, MSCE
Outcome results
None listed