Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
110 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-07-20
Study Completion Date
2027-02-28
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.
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Detailed Description
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Conditions
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Neonatal Respiratory Failure
Tracheal Intubation Morbidity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel group open-label randomized controlled trial.
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Apneic Oxygenation
Group Type
EXPERIMENTAL
Apneic Oxygenation
Intervention Type
PROCEDURE
Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)
Standard of Care
Group Type
ACTIVE_COMPARATOR
Standard of Care
Intervention Type
PROCEDURE
No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)
Interventions
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Apneic Oxygenation
Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)
Intervention Type
PROCEDURE
Standard of Care
No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
1. Infants ≥28 weeks corrected gestational age
2. Undergoing intubation in the NICU
3. Pre-medication (including paralytic) administered
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
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
Minimum Eligible Age
0 Days
Maximum Eligible Age
365 Days
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
Children's Hospital of Philadelphia
OTHER
Sponsor Role
collaborator
University of Pennsylvania
OTHER
Sponsor Role
lead
Responsible Party
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Elizabeth Foglia
Assistant Professor of Pediatrics
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Elizabeth Foglia, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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References
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Lee JH, Turner DA, Kamat P, Nett S, Shults J, Nadkarni VM, Nishisaki A; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI); National Emergency Airway Registry for Children (NEAR4KIDS). The number of tracheal intubation attempts matters! A prospective multi-institutional pediatric observational study. BMC Pediatr. 2016 Apr 29;16:58. doi: 10.1186/s12887-016-0593-y.
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Reference Type
DERIVED
Other Identifiers
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19-017190
Identifier Type: -
Identifier Source: org_study_id
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