Providing Oxygen During Intubation in the NICU Trial

Not Applicable

Recruiting

• Conditions: Tracheal Intubation Morbidity; Neonatal Respiratory Failure
• Interventions: Procedure: Apneic Oxygenation; Procedure: Standard of Care

• Registration Number: NCT05451953
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-11
• Study Start: 2022-07-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apneic Oxygenation	Apneic Oxygenation	-
Standard of Care	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States