Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

NCT06202144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • Acute Hypoxic Respiratory Failure

Interventions

DEVICE

Noninvasive support

Noninvasive respiratory support delivered through a helmet

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Domenico Luca Grieco · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2025-06-01
Completion
2025-06-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202144 on ClinicalTrials.gov