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Optimal High CPAP Pressures in Preterm Neonates Post-extubation

Primary Purpose

Preterm Birth, Mechanical Ventilation Complication, Respiratory Distress Syndrome, Newborn

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CPAP level
Sponsored by
McMaster Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Birth focused on measuring Continuous Positive Airway Pressure, Electrical activity of diaphragm, Continuous distending pressure

Eligibility Criteria

7 Days - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age <29 weeks; chronological age >7 days; post-menstrual age <37 weeks; extubation from invasive ventilation with measured mean airway pressure 9-15 cmH2O

Exclusion Criteria:

  • Any congenital or genetic/chromosomal abnormality

Sites / Locations

  • McMaster Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Higher CPAP

Equivalent CPAP

Arm Description

CPAP level will be 2 cmH2O higher than pre-extubation measured mean airway pressure

CPAP level will be equal to the pre-extubation measured mean airway pressure

Outcomes

Primary Outcome Measures

Peak Edi
The peak electrical diaphragmatic activity - a surrogate for work of breathing to generate tidal volume

Secondary Outcome Measures

Minimum EDi
The minimum eelectrical diaphragmatic activity - a surrogate for work of breathing to maintain functional residual capacity
Regional cerebral perfusion
The cerebral tissue extraction of oxygen - determined by near infra-red spectroscopy
Pressure level - Ventilator
Pressure level as measured by the ventilator
Pressure level - Interface
Pressure level at measured at the nasal interface used to deliver CPAP
Work of breathing score
Using Silverman Scoring
Heart Rate
From cardiorespiratory monitoring
Respiratory Rate
From cardiorespiratory monitoring
Transcutaneous CO2 level
From bedside transcutaneous CO2 monitoring
FiO2 level
Fractional inspired oxygen level, as determined by clinical and inputted into ventilator
Number of bradycardic episodes <80 bpm
as above
Proportion of duration with SpO2 <90%
duration of time where the patient's SpO2 is less than 90%

Full Information

First Posted
January 28, 2022
Last Updated
January 28, 2022
Sponsor
McMaster Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05230485
Brief Title
Optimal High CPAP Pressures in Preterm Neonates Post-extubation
Official Title
Optimal High CPAP Pressures in Preterm Neonates Post-extubation: A Prospective Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2022 (Anticipated)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. In this study, we will comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.
Detailed Description
Background: Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. However, there are limited data on the effectiveness and safety of this mode. A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. While it could be argued that the initial High CPAP pressure post-extubation should be somewhat higher than the pre-extubation mean airway pressure (Paw), there remain concerns of potential complications as well as uncertainty around degree of leak and resulting effectiveness. On the other hand, a suboptimal post-extubation High CPAP level may lead to atelectasis and contribute towards extubation failure, potentially prolonging invasive ventilation and associated risks. As such, research towards identification of the optimal High CPAP level post-extubation from high invasive ventilation pressures is warranted. Objective: To comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates. Hypothesis: We hypothesize that babies extubated from invasive mechanical ventilation with a mean Paw between 9-15 cmH2O will demonstrate better physiological and clinical parameters when using High CPAP+2 cmH2O vs equivalent CPAP levels. Methods: Design - This will be a prospective, single-centre, randomized cross-over study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Mechanical Ventilation Complication, Respiratory Distress Syndrome, Newborn
Keywords
Continuous Positive Airway Pressure, Electrical activity of diaphragm, Continuous distending pressure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Higher CPAP
Arm Type
Experimental
Arm Description
CPAP level will be 2 cmH2O higher than pre-extubation measured mean airway pressure
Arm Title
Equivalent CPAP
Arm Type
Active Comparator
Arm Description
CPAP level will be equal to the pre-extubation measured mean airway pressure
Intervention Type
Other
Intervention Name(s)
CPAP level
Intervention Description
The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP
Primary Outcome Measure Information:
Title
Peak Edi
Description
The peak electrical diaphragmatic activity - a surrogate for work of breathing to generate tidal volume
Time Frame
60 min following each CPAP level - assessed over 10 min
Secondary Outcome Measure Information:
Title
Minimum EDi
Description
The minimum eelectrical diaphragmatic activity - a surrogate for work of breathing to maintain functional residual capacity
Time Frame
60 min following each CPAP level - assessed over 10 min
Title
Regional cerebral perfusion
Description
The cerebral tissue extraction of oxygen - determined by near infra-red spectroscopy
Time Frame
60 min following each CPAP level - assessed over 10 min
Title
Pressure level - Ventilator
Description
Pressure level as measured by the ventilator
Time Frame
60 min following each CPAP level - assessed over 10 min
Title
Pressure level - Interface
Description
Pressure level at measured at the nasal interface used to deliver CPAP
Time Frame
60 min following each CPAP level - assessed over 10 min
Title
Work of breathing score
Description
Using Silverman Scoring
Time Frame
Over entire duration (70 min) at each CPAP level, assessed every 10 min
Title
Heart Rate
Description
From cardiorespiratory monitoring
Time Frame
Over entire duration (70 min) at each CPAP level, assessed every 10 min
Title
Respiratory Rate
Description
From cardiorespiratory monitoring
Time Frame
Over entire duration (70 min) at each CPAP level, assessed every 10 min
Title
Transcutaneous CO2 level
Description
From bedside transcutaneous CO2 monitoring
Time Frame
Over entire duration (70 min) at each CPAP level, assessed every 10 min
Title
FiO2 level
Description
Fractional inspired oxygen level, as determined by clinical and inputted into ventilator
Time Frame
Over entire duration (70 min) at each CPAP level, assessed every 10 min
Title
Number of bradycardic episodes <80 bpm
Description
as above
Time Frame
Over entire duration (70 min) at each CPAP level
Title
Proportion of duration with SpO2 <90%
Description
duration of time where the patient's SpO2 is less than 90%
Time Frame
Over entire duration (70 min) at each CPAP level

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age <29 weeks; chronological age >7 days; post-menstrual age <37 weeks; extubation from invasive ventilation with measured mean airway pressure 9-15 cmH2O Exclusion Criteria: Any congenital or genetic/chromosomal abnormality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Mukerji, MD
Phone
905-521-2100
Ext
76486
Email
mukerji@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Mukerji, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimal High CPAP Pressures in Preterm Neonates Post-extubation

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