Providing Oxygen During Intubation in the NICU Trial

N/ARecruitingNCT05451953

University of Pennsylvania110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

110

Conditions

Neonatal Respiratory Failure Tracheal Intubation Morbidity

Interventions

Eligibility

Sex: ALLMin age: 0 DaysMax age: 365 Days

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: During intubation procedure

Secondary Outcomes

Secondary Clinical Outcome: Severe oxygen desaturation

≥20% decline in SpO2

Time frame: During intubation procedure

Secondary Clinical Outcome: SpO2<80%

SpO2\<80% at any point

Time frame: During intubation procedure

Secondary Clinical Outcome: Time to SpO2 <80%

Time to SpO2 \<80% from facemask removal

Time frame: During intubation procedure

Secondary Clinical Outcome: intubation success

First intubation attempt success

Time frame: During intubation procedure

Secondary Clinical Outcome: Number of intubation attempts

Total number of intubation attempts

Time frame: During intubation procedure

Secondary Clinical Outcome: Duration of intubation attempts

Duration of each intubation attempt

Time frame: During intubation procedure

Secondary Clinical Outcome: Change in pulse rate

Difference between highest and lowest pulse rate

Time frame: During intubation procedure

Secondary Clinical Outcome: pH

First blood gas pH

Time frame: Three hours after intubation

Secondary Clinical Outcome: pCO2

First blood gas pCO2

Time frame: Three hours after intubation

Secondary Clinical Outcome: PaO2

First blood gas PaO2 (for infants with indwelling arterial lines)

Time frame: Three hours after intubation

Feasibility Outcome: AO fidelity

Proportion subjects allocated to AO successfully provided the AO intervention

Time frame: During the intubation procedure

Feasibility Outcome: Protocol deviations

Number of protocol deviations and violations

Time frame: During intubation procedure

Feasibility Outcome: Screening

Proportion of intubated infants successfully screened in advance

Time frame: Through study completion, an average of 18 months.

Feasibility Outcome: Recruitment

Rates of informed consent

Time frame: Through study completion, an average of 18 months.

Feasibility Outcome: Randomization

Proportion of consented infants who were randomized

Time frame: Through study completion, an average of 18 months.

Central Contacts

Heidi Herrick, MD, MSCE

CONTACT

267-408-6146 herrickh@chop.edu

Elizabeth Foglia, MD, MSCE

CONTACT

267-441-7144 foglia@chop.edu

Providing Oxygen During Intubation in the NICU Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts