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Clinical Trials/NCT06210386
NCT06210386
Completed
Not Applicable

Physiological Effects of Helmet vs. Facemask Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country20 target enrollmentJanuary 19, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Hypoxemic Respiratory Failure
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
20
Locations
1
Primary Endpoint
Inspiratory effort
Status
Completed
Last Updated
7 months ago

Overview

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. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort.

In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).

Registry
clinicaltrials.gov
Start Date
January 19, 2024
End Date
September 15, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Outcomes

Primary Outcomes

Inspiratory effort

Time Frame: 1 hour

negative deflection in esophageal pressure

End-expiratory lung impedance

Time Frame: 1 hour

Electrical-impedance derived end-expiratory lung volume

Secondary Outcomes

  • Tidal volume(1 hour)
  • Discomfort(1 hour)
  • Oxygenation(1 hour)
  • Corrected minute ventilation(1 hour)
  • Dynamic transpulmonary driving pressure(1 hour)
  • Work of breathing(1 hour)
  • Respiratory rate(1 hour)
  • Dyspnea(1 hour)
  • Pendelluft extent(1 hour)
  • Compliance(1 hour)
  • Arteria Carbon dioxide tension(1 hour)
  • Tidal volume distribution(1 hour)

Study Sites (1)

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