Status:

COMPLETED

Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Acute Hypoxic Respiratory Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

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 sequentia...

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 support
  • 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 12 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 15 2025

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06202144

Start Date

January 12 2024

End Date

June 15 2025

Last Update

September 30 2025

Active Locations (1)

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Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

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