NCT06202144

Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

Physiological Effects of Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The optimal noninvasive respiratory support for acute hypoxemic respiratory failure is debated. Recent preliminary data indicate that both pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP) may be of benefit. While often applied interchangeably in clinical practice, NIV and CPAP have different effects on the inspiratory effort, which is the major determinant of self-inflicted lung injury. Also, inspiratory effort widely varies among individuals. The purpose of this study is to assess the physiological effects of a noninvasive respiratory support approach guided by inspiratory effort, as compared to CPAP and NIV, in patients with moderate-to-severe acute hypoxemic respiratory failure.

Detailed description

Patients with acute hypoxemic respiratory failure will undergo a decremental pressure-support trial during helmet noninvasive support. The following pressure-support settings will be applied sequentially, with positive end-expiratory pressure kept constant and equal to 10-12 cmH2O: 20 cmH2O, 16 cmH2O, 12 cmH2O, 8 cmH2O and high-flow-driven CPAP. Inspiratory effort will be monitored during the trial through esophageal manometry. The personalized setting of noninvasive support will be defined as the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O. Personalized noninvasive support will be then compared to conventionally-set NIV and CPAP in a randomized cross-over trial.

Conditions

• Acute Hypoxic Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Noninvasive support	Noninvasive respiratory support delivered through a helmet

Timeline

• Start date: 2024-01-12
• Primary completion: 2025-06-01
• Completion: 2025-06-15
• First posted: 2024-01-11
• Last updated: 2025-09-30

Locations

1 site across 1 country: Italy