Status:

COMPLETED

Physiology of Helmet vs. Facemask Noninvasive Ventilation

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Acute Hypoxemic Respiratory Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Put...

Eligibility Criteria

Inclusion

  • Acute hypoxemic respiratory failure and PaO2/FiO2\<200 mmHg
  • PaCO2\<45 mmHg
  • Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload

Exclusion

  • Pregnancy
  • Contraindication to helmet or facemask noninvasive ventilation
  • Contraindication to esophageal manometry
  • Contraindication to electrical-impedance tomography monitoring
  • Recent surgery involving the abdomen or the thorax
  • Pneumothorax or documented barotrauma

Key Trial Info

Start Date :

January 19 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 15 2025

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06210386

Start Date

January 19 2024

End Date

September 15 2025

Last Update

September 30 2025

Active Locations (1)

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Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy