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NCT06210386 Clinical Trial

Physiology of Helmet vs. Facemask Noninvasive Ventilation

Acute Hypoxemic Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06210386
Other study ID # 5173-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2024
Est. completion date January 15, 2025

Study information
Verified date December 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Domenico L Grieco, MD
Phone +393397681623
Email dlgrieco@outlook.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date January 15, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Noninvasive ventilation
noninvasive ventilation

Locations
Country Name City State
Italy Fondazione Policlinico Universitaro A. Gemelli IRCCS Rome

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inspiratory effort negative deflection in esophageal pressure 1 hour
Primary End-expiratory lung impedance Electrical-impedance derived end-expiratory lung volume 1 hour
Secondary Tidal volume Electrical-impedance derived tidal volume size 1 hour
Secondary Work of breathing Esophageal pressure simplified pressure-time product 1 hour
Secondary Respiratory rate Respiratory rate per minute 1 hour
Secondary Dynamic transpulmonary driving pressure Tidal change in transpulmonary pressure 1 hour
Secondary Compliance Ratio of tidal volume to transpulmonary driving pressure 1 hour
Secondary Dyspnea Dyspnea rated through a visual analog scale (ranging from 0 to 10, with representing most severe dyspnea) adapted for critically ill patients 1 hour
Secondary Discomfort Device-related discomfort (ranging from 0 to 10, with representing most severe dyspnea) rated through a visual analog scale adapted for critically ill patients 1 hour
Secondary Oxygenation PaO2/FiO2 ratio 1 hour
Secondary Pendelluft extent Pendelluft extent, expressed in % of the total tidal volume 1 hour
Secondary Corrected minute ventilation 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 1 hour
Secondary Arteria Carbon dioxide tension PaCO2 1 hour
Secondary Tidal volume distribution Tidal volume distribution, assessed with electrical impedance tomography in 4 regions of interest (ventral, mid-ventral, mid-dorsal, dorsal) 1 hour
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