Clincosm LogoSign in Get a demo

POINT: Providing Oxygen During Intubation in the NICU Trial

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05451953
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Children's Hospital of Philadelphia (Other)
110
Enrollment
1
Location
2
Arms
17.4
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Apneic Oxygenation
  • Procedure: Standard of Care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel group open-label randomized controlled trial.Parallel group open-label randomized controlled trial.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU
Actual Study Start Date :
Jul 21, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Apneic Oxygenation

Procedure: Apneic Oxygenation
Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)
Active Comparator: Standard of Care

Procedure: Standard of Care
No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Secondary Clinical Outcome: Severe oxygen desaturation [During intubation procedure]

    ≥20% decline in SpO2

  2. Secondary Clinical Outcome: SpO2<80% [During intubation procedure]

    SpO2<80% at any point

  3. Secondary Clinical Outcome: Time to SpO2 <80% [During intubation procedure]

    Time to SpO2 <80% from facemask removal

  4. Secondary Clinical Outcome: intubation success [During intubation procedure]

    First intubation attempt success

  5. Secondary Clinical Outcome: Number of intubation attempts [During intubation procedure]

    Total number of intubation attempts

  6. Secondary Clinical Outcome: Duration of intubation attempts [During intubation procedure]

    Duration of each intubation attempt

  7. Secondary Clinical Outcome: Change in pulse rate [During intubation procedure]

    Difference between highest and lowest pulse rate

  8. Secondary Clinical Outcome: pH [Three hours after intubation]

    First blood gas pH

  9. Secondary Clinical Outcome: pCO2 [Three hours after intubation]

    First blood gas pCO2

  10. Secondary Clinical Outcome: PaO2 [Three hours after intubation]

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

  11. Feasibility Outcome: AO fidelity [During the intubation procedure]

    Proportion subjects allocated to AO successfully provided the AO intervention

  12. Feasibility Outcome: Protocol deviations [During intubation procedure]

    Number of protocol deviations and violations

  13. Feasibility Outcome: Screening [Through study completion, an average of 18 months.]

    Proportion of intubated infants successfully screened in advance

  14. Feasibility Outcome: Recruitment [Through study completion, an average of 18 months.]

    Rates of informed consent

  15. Feasibility Outcome: Randomization [Through study completion, an average of 18 months.]

    Proportion of consented infants who were randomized

Other Outcome Measures

  1. Safety Outcome: Cardiopulmonary resuscitation [During or within 1 hour of procedure]

    Chest compressions with or without epinephrine

  2. Safety Outcome: Air Leaks [Within 24 hours of procedure]

    New pneumothorax

  3. Safety Outcome: Nasal Trauma [Within 24 hours of procedure]

    New nasal trauma

  4. Safety Outcome: adverse Tracheal Intubation Adverse Events [During Intubation Procedure]

    Tracheal Intubation Adverse Events, per NEAR4NEOS definitions

  5. Safety Outcome: Duration of time with 100% SpO2 [During Intubation Procedure]

    Duration of time with SpO2=100%

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Days and Older
Sexes Eligible for Study:
All
Accepts 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. History of 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Elizabeth Foglia, MD, MSCE, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elizabeth Foglia, Assistant Professor of Pediatrics, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05451953
Other Study ID Numbers:
  • 19-017190
  • R21HD103927
First Posted:
Jul 11, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elizabeth Foglia, Assistant Professor of Pediatrics, University of Pennsylvania
Apneic Oxygenation
Tracheal Intubation
Neonate
Additional relevant MeSH terms:
Respiratory Insufficiency

Study Results

No Results Posted as of Aug 3, 2022