Optimal High CPAP Pressures in Preterm Neonates Post-extubation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preterm Birth; Respiratory Distress Syndrome, Newborn; Mechanical Ventilation Complication
• Intervention / Treatment: Other: CPAP level

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 Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S4K1
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster Children's Hospital
• Investigators: Principal Investigator: Amit Mukerji, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2022
• Primary Completion (Anticipated): February 15, 2024
• Study Completion (Anticipated): February 15, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Electrical activity of diaphragm; Continuous distending pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 14289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No