NCT05230485

Optimal High CPAP Pressures in Preterm Neonates Post-extubation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: McMaster Children's Hospital · Academic / Other
• Sex: All
• Age: 7 Days – 37 Weeks
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	CPAP level	The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP

Timeline

• Start date: 2022-02-15
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2022-02-09
• Last updated: 2022-02-09

Locations

1 site across 1 country: Canada