Optimal High CPAP Pressures in Preterm Neonates Post-extubation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimal High CPAP Pressures in Preterm Neonates Post-extubation: A Prospective Randomized Crossover Trial

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

Intervention / Treatment
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* Other: CPAP level


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Higher CPAP<br>CPAP level will be 2 cmH2O higher than pre-extubation measured mean airway pressure | Other: CPAP level<br>* The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP<br>|
| Active Comparator: Equivalent CPAP<br>CPAP level will be equal to the pre-extubation measured mean airway pressure | Other: CPAP level<br>* The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Edi | The peak electrical diaphragmatic activity - a surrogate for work of breathing to generate tidal volume | 60 min following each CPAP level - assessed over 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum EDi | The minimum eelectrical diaphragmatic activity - a surrogate for work of breathing to maintain functional residual capacity | 60 min following each CPAP level - assessed over 10 min | 
| Regional cerebral perfusion | The cerebral tissue extraction of oxygen - determined by near infra-red spectroscopy | 60 min following each CPAP level - assessed over 10 min | 
| Pressure level - Ventilator | Pressure level as measured by the ventilator | 60 min following each CPAP level - assessed over 10 min | 
| Pressure level - Interface | Pressure level at measured at the nasal interface used to deliver CPAP | 60 min following each CPAP level - assessed over 10 min | 
| Work of breathing score | Using Silverman Scoring | Over entire duration (70 min) at each CPAP level, assessed every 10 min | 
| Heart Rate | From cardiorespiratory monitoring | Over entire duration (70 min) at each CPAP level, assessed every 10 min | 
| Respiratory Rate | From cardiorespiratory monitoring | Over entire duration (70 min) at each CPAP level, assessed every 10 min | 
| Transcutaneous CO2 level | From bedside transcutaneous CO2 monitoring | Over entire duration (70 min) at each CPAP level, assessed every 10 min | 
| FiO2 level | Fractional inspired oxygen level, as determined by clinical and inputted into ventilator | Over entire duration (70 min) at each CPAP level, assessed every 10 min | 
| Number of bradycardic episodes <80 bpm | as above | Over entire duration (70 min) at each CPAP level | 
| Proportion of duration with SpO2 <90% | duration of time where the patient's SpO2 is less than 90% | Over entire duration (70 min) at each CPAP level | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Positive Airway Pressure, Electrical activity of diaphragm, Continuous distending pressure