Optimal High CPAP Pressures in Preterm Neonates Post-extubation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Higher CPAP CPAP level will be 2 cmH2O higher than pre-extubation measured mean airway pressure |
Other: CPAP level
The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP
|
| Active Comparator: Equivalent CPAP CPAP level will be equal to the pre-extubation measured mean airway pressure |
Other: CPAP level
The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP
|
Outcome Measures
Primary Outcome Measures
- Peak Edi [60 min following each CPAP level - assessed over 10 min]
The peak electrical diaphragmatic activity - a surrogate for work of breathing to generate tidal volume
Secondary Outcome Measures
- Minimum EDi [60 min following each CPAP level - assessed over 10 min]
The minimum eelectrical diaphragmatic activity - a surrogate for work of breathing to maintain functional residual capacity
- Regional cerebral perfusion [60 min following each CPAP level - assessed over 10 min]
The cerebral tissue extraction of oxygen - determined by near infra-red spectroscopy
- Pressure level - Ventilator [60 min following each CPAP level - assessed over 10 min]
Pressure level as measured by the ventilator
- Pressure level - Interface [60 min following each CPAP level - assessed over 10 min]
Pressure level at measured at the nasal interface used to deliver CPAP
- Work of breathing score [Over entire duration (70 min) at each CPAP level, assessed every 10 min]
Using Silverman Scoring
- Heart Rate [Over entire duration (70 min) at each CPAP level, assessed every 10 min]
From cardiorespiratory monitoring
- Respiratory Rate [Over entire duration (70 min) at each CPAP level, assessed every 10 min]
From cardiorespiratory monitoring
- Transcutaneous CO2 level [Over entire duration (70 min) at each CPAP level, assessed every 10 min]
From bedside transcutaneous CO2 monitoring
- FiO2 level [Over entire duration (70 min) at each CPAP level, assessed every 10 min]
Fractional inspired oxygen level, as determined by clinical and inputted into ventilator
- Number of bradycardic episodes <80 bpm [Over entire duration (70 min) at each CPAP level]
as above
- Proportion of duration with SpO2 <90% [Over entire duration (70 min) at each CPAP level]
duration of time where the patient's SpO2 is less than 90%
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McMaster Children's Hospital | Hamilton | Ontario | Canada | L8S4K1 |
Sponsors and Collaborators
- McMaster Children's Hospital
Investigators
- Principal Investigator: Amit Mukerji, MD, Associate Professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14289