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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05230485
Other study ID # 14289
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date February 15, 2024

Study information

Verified date January 2022
Source McMaster Children's Hospital
Contact Amit Mukerji, MD
Phone 905-521-2100
Email mukerji@mcmaster.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 26
Est. completion date February 15, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 37 Weeks
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
CPAP level
The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP

Locations

Country Name City State
Canada McMaster Children's Hospital Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Pressure level - Ventilator Pressure level as measured by the ventilator 60 min following each CPAP level - assessed over 10 min
Secondary 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
Secondary Work of breathing score Using Silverman Scoring Over entire duration (70 min) at each CPAP level, assessed every 10 min
Secondary Heart Rate From cardiorespiratory monitoring Over entire duration (70 min) at each CPAP level, assessed every 10 min
Secondary Respiratory Rate From cardiorespiratory monitoring Over entire duration (70 min) at each CPAP level, assessed every 10 min
Secondary Transcutaneous CO2 level From bedside transcutaneous CO2 monitoring Over entire duration (70 min) at each CPAP level, assessed every 10 min
Secondary 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
Secondary Number of bradycardic episodes <80 bpm as above Over entire duration (70 min) at each CPAP level
Secondary 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
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