RecruitingNot ApplicableNCT05451953

Providing Oxygen During Intubation in the NICU Trial

Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU


Sponsor

University of Pennsylvania

Enrollment

110 participants

Start Date

Jul 20, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 DaysMax Age: 365 Days

Plain Language Summary

Simplified for easier understanding

This study looks at whether providing oxygen during the process of placing a breathing tube (intubation) in premature babies in the NICU improves safety and outcomes. Intubation can cause a drop in oxygen levels, and this trial tests whether giving supplemental oxygen during the procedure helps. You may be eligible if: - Your baby is 28 weeks gestational age or older - Your baby is in the NICU and needs to be intubated - Pre-medications including a paralytic were given before the procedure You may NOT be eligible if: - Your baby has a known difficult or abnormal airway - Your baby has unstable vital signs or is being actively resuscitated - Oxygen levels could not be raised to 90% or above before the attempt - The intubation is being done by a non-NICU provider (e.g., anesthesiology or ENT) - Your baby has an unrepaired congenital diaphragmatic hernia, tracheoesophageal fistula within 2 weeks of repair, or a tracheostomy - Your baby has previously been enrolled in this trial - Your baby is undergoing nasal intubation - Your baby has tested positive for COVID-19 or is under investigation - Your baby has cyanotic heart disease, is on ECMO support, or is a conjoined twin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)


Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT05451953


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