Optimal High CPAP Pressures in Preterm Neonates Post-extubation

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05230485
• Other study ID #: 14289
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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