Providing Oxygen During Intubation in the NICU Trial (POINT)
Primary Purpose
Neonatal Respiratory Failure, Tracheal Intubation Morbidity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apneic Oxygenation
Standard of Care
Sponsored by
About this trial
This is an interventional prevention trial for Neonatal Respiratory Failure focused on measuring Apneic Oxygenation, Tracheal Intubation, Neonate
Eligibility Criteria
Inclusion Criteria:
- Infants ≥28 weeks corrected gestational age
- Undergoing intubation in the NICU
- Pre-medication (including paralytic) administered
Exclusion Criteria:
- History of critical airway or airway anomaly
- Unstable hemodynamics (i.e. active resuscitation)
- Unable to achieve SpO2 ≥90% prior to intubation attempt
- Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
- Unrepaired congenital diagrammatic hernia
- Tracheal esophageal fistula within 2 weeks of repair
- Tracheostomy
- Previous enrollment in the trial
- Nasal intubation
- COVID person under investigation (PUI) or COVID positive
Sites / Locations
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Apneic Oxygenation
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary Clinical Outcome: Severe oxygen desaturation
≥20% decline in SpO2
Secondary Clinical Outcome: SpO2<80%
SpO2<80% at any point
Secondary Clinical Outcome: Time to SpO2 <80%
Time to SpO2 <80% from facemask removal
Secondary Clinical Outcome: intubation success
First intubation attempt success
Secondary Clinical Outcome: Number of intubation attempts
Total number of intubation attempts
Secondary Clinical Outcome: Duration of intubation attempts
Duration of each intubation attempt
Secondary Clinical Outcome: Change in pulse rate
Difference between highest and lowest pulse rate
Secondary Clinical Outcome: pH
First blood gas pH
Secondary Clinical Outcome: pCO2
First blood gas pCO2
Secondary Clinical Outcome: PaO2
First blood gas PaO2 (for infants with indwelling arterial lines)
Feasibility Outcome: AO fidelity
Proportion subjects allocated to AO successfully provided the AO intervention
Feasibility Outcome: Protocol deviations
Number of protocol deviations and violations
Feasibility Outcome: Screening
Proportion of intubated infants successfully screened in advance
Feasibility Outcome: Recruitment
Rates of informed consent
Feasibility Outcome: Randomization
Proportion of consented infants who were randomized
Full Information
NCT ID
NCT05451953
First Posted
June 7, 2022
Last Updated
March 23, 2023
Sponsor
University of Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT05451953
Brief Title
Providing Oxygen During Intubation in the NICU Trial
Acronym
POINT
Official Title
Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Failure, Tracheal Intubation Morbidity
Keywords
Apneic Oxygenation, Tracheal Intubation, Neonate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group open-label randomized controlled trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apneic Oxygenation
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Apneic Oxygenation
Intervention Description
Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)
Primary Outcome Measure Information:
Title
Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)
Description
Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter.
Time Frame
During intubation procedure
Secondary Outcome Measure Information:
Title
Secondary Clinical Outcome: Severe oxygen desaturation
Description
≥20% decline in SpO2
Time Frame
During intubation procedure
Title
Secondary Clinical Outcome: SpO2<80%
Description
SpO2<80% at any point
Time Frame
During intubation procedure
Title
Secondary Clinical Outcome: Time to SpO2 <80%
Description
Time to SpO2 <80% from facemask removal
Time Frame
During intubation procedure
Title
Secondary Clinical Outcome: intubation success
Description
First intubation attempt success
Time Frame
During intubation procedure
Title
Secondary Clinical Outcome: Number of intubation attempts
Description
Total number of intubation attempts
Time Frame
During intubation procedure
Title
Secondary Clinical Outcome: Duration of intubation attempts
Description
Duration of each intubation attempt
Time Frame
During intubation procedure
Title
Secondary Clinical Outcome: Change in pulse rate
Description
Difference between highest and lowest pulse rate
Time Frame
During intubation procedure
Title
Secondary Clinical Outcome: pH
Description
First blood gas pH
Time Frame
Three hours after intubation
Title
Secondary Clinical Outcome: pCO2
Description
First blood gas pCO2
Time Frame
Three hours after intubation
Title
Secondary Clinical Outcome: PaO2
Description
First blood gas PaO2 (for infants with indwelling arterial lines)
Time Frame
Three hours after intubation
Title
Feasibility Outcome: AO fidelity
Description
Proportion subjects allocated to AO successfully provided the AO intervention
Time Frame
During the intubation procedure
Title
Feasibility Outcome: Protocol deviations
Description
Number of protocol deviations and violations
Time Frame
During intubation procedure
Title
Feasibility Outcome: Screening
Description
Proportion of intubated infants successfully screened in advance
Time Frame
Through study completion, an average of 18 months.
Title
Feasibility Outcome: Recruitment
Description
Rates of informed consent
Time Frame
Through study completion, an average of 18 months.
Title
Feasibility Outcome: Randomization
Description
Proportion of consented infants who were randomized
Time Frame
Through study completion, an average of 18 months.
Other Pre-specified Outcome Measures:
Title
Safety Outcome: Cardiopulmonary resuscitation
Description
Chest compressions with or without epinephrine
Time Frame
During or within 1 hour of procedure
Title
Safety Outcome: Air Leaks
Description
New pneumothorax
Time Frame
Within 24 hours of procedure
Title
Safety Outcome: Nasal Trauma
Description
New nasal trauma
Time Frame
Within 24 hours of procedure
Title
Safety Outcome: adverse Tracheal Intubation Adverse Events
Description
Tracheal Intubation Adverse Events, per NEAR4NEOS definitions
Time Frame
During Intubation Procedure
Title
Safety Outcome: Duration of time with 100% SpO2
Description
Duration of time with SpO2=100%
Time Frame
During Intubation Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants ≥28 weeks corrected gestational age
Undergoing intubation in the NICU
Pre-medication (including paralytic) administered
Exclusion Criteria:
Critical Airway or Airway Anomaly
Unstable hemodynamics (i.e. active resuscitation)
Unable to achieve SpO2 ≥90% prior to intubation attempt
Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
Unrepaired congenital diagrammatic hernia
Tracheal esophageal fistula within 2 weeks of repair
Tracheostomy
Previous enrollment in the trial
Nasal intubation
COVID person under investigation (PUI) or COVID positive
Cyanotic heart disease
Receiving Extracorporeal Membrane Oxygenation support
Conjoined twins
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Herrick, MD, MSCE
Phone
267-408-6146
Email
herrickh@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Foglia, MD, MSCE
Phone
267-441-7144
Email
foglia@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Foglia, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The PI will make data available after study completion and in accordance with NIH policies. Our data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the institution's IRB or demonstration of IRB exemption per institutional policy. The data and the associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
IPD Sharing Time Frame
After study completion.
IPD Sharing Access Criteria
Data use agreement in place prior to data sharing.
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Providing Oxygen During Intubation in the NICU Trial
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