Providing Oxygen During Intubation in the NICU Trial

Study Overview
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Brief Summary
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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
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Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU

Conditions
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Neonatal Respiratory Failure, Tracheal Intubation Morbidity

Intervention / Treatment
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* Procedure: Apneic Oxygenation
* Procedure: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants ≥28 weeks corrected gestational age Undergoing intubation in the NICU Pre-medication (including paralytic) administered Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 365 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group open-label randomized controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apneic Oxygenation<br> | Procedure: Apneic Oxygenation<br>* Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)<br>|
| Active Comparator: Standard of Care<br> | Procedure: Standard of Care<br>* No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Clinical Outcome: Severe oxygen desaturation | ≥20% decline in SpO2 | During intubation procedure | 
| Secondary Clinical Outcome: SpO2<80% | SpO2<80% at any point | During intubation procedure | 
| Secondary Clinical Outcome: Time to SpO2 <80% | Time to SpO2 <80% from facemask removal | During intubation procedure | 
| Secondary Clinical Outcome: intubation success | First intubation attempt success | During intubation procedure | 
| Secondary Clinical Outcome: Number of intubation attempts | Total number of intubation attempts | During intubation procedure | 
| Secondary Clinical Outcome: Duration of intubation attempts | Duration of each intubation attempt | During intubation procedure | 
| Secondary Clinical Outcome: Change in pulse rate | Difference between highest and lowest pulse rate | During intubation procedure | 
| Secondary Clinical Outcome: pH | First blood gas pH | Three hours after intubation | 
| Secondary Clinical Outcome: pCO2 | First blood gas pCO2 | Three hours after intubation | 
| Secondary Clinical Outcome: PaO2 | First blood gas PaO2 (for infants with indwelling arterial lines) | Three hours after intubation | 
| Feasibility Outcome: AO fidelity | Proportion subjects allocated to AO successfully provided the AO intervention | During the intubation procedure | 
| Feasibility Outcome: Protocol deviations | Number of protocol deviations and violations | During intubation procedure | 
| Feasibility Outcome: Screening | Proportion of intubated infants successfully screened in advance | Through study completion, an average of 18 months. | 
| Feasibility Outcome: Recruitment | Rates of informed consent | Through study completion, an average of 18 months. | 
| Feasibility Outcome: Randomization | Proportion of consented infants who were randomized | Through study completion, an average of 18 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apneic Oxygenation, Tracheal Intubation, Neonate