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Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure

NCT05089695 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-09-30

No results posted yet for this study

Summary

Multicenter, open label, three-arm randomized trial to assess the effect of helmet noninvasive ventilation vs. helmet continuous positive airway pressure vs. high-flow nasal oxygen on the rate of endotracheal intubation of patients with acute moderate-to-severe hypoxemic respiratory failure

Conditions

Interventions

DEVICE

Noninvasive respiratory support

Treatment of acute hypoxemic respiratory failure

Sponsors & Collaborators

  • Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

    collaborator OTHER

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

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

  • Massimo Antonelli, MD · Fondazione Policlinico A. Gemelli IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT05089695 on ClinicalTrials.gov