Physiology of Helmet vs. Facemask Noninvasive Ventilation

Not Applicable

Recruiting

• Conditions: Acute Hypoxemic Respiratory Failure

• Registration Number: NCT06210386
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-18
• Study Start: 2024-01-19
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Inspiratory effort	1 hour	negative deflection in esophageal pressure
End-expiratory lung impedance	1 hour	Electrical-impedance derived end-expiratory lung volume

Secondary Outcome Measures

Name	Time	Method
Tidal volume	1 hour	Electrical-impedance derived tidal volume size
Discomfort	1 hour	Device-related discomfort (ranging from 0 to 10, with representing most severe dyspnea) rated through a visual analog scale adapted for critically ill patients
Oxygenation	1 hour	PaO2/FiO2 ratio
Corrected minute ventilation	1 hour	The product of tidal volume and respiratory rate, normalized to PaCO2. This value is expressed in Arbitrary units per minute divided by mmHg and is a proxy of dead space
Dynamic transpulmonary driving pressure	1 hour	Tidal change in transpulmonary pressure
Work of breathing	1 hour	Esophageal pressure simplified pressure-time product
Respiratory rate	1 hour	Respiratory rate per minute
Dyspnea	1 hour	Dyspnea rated through a visual analog scale (ranging from 0 to 10, with representing most severe dyspnea) adapted for critically ill patients
Pendelluft extent	1 hour	Pendelluft extent, expressed in % of the total tidal volume
Compliance	1 hour	Ratio of tidal volume to transpulmonary driving pressure
Arteria Carbon dioxide tension	1 hour	PaCO2
Tidal volume distribution	1 hour	Tidal volume distribution, assessed with electrical impedance tomography in 4 regions of interest (ventral, mid-ventral, mid-dorsal, dorsal)

Trial Locations

Locations (1)

Fondazione Policlinico Universitaro A. Gemelli IRCCS; 🇮🇹 Rome, Italy