Physiology of Helmet vs. Facemask Noninvasive Ventilation

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Acute Hypoxemic Respiratory Failure

Treatments: Device: Noninvasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT06210386

5173-1

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Helmet noninvasive ventilation

Experimental group

Description:

1-hour treatment with helmet noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O).

Treatment:

Device: Noninvasive ventilation

Facemask noninvasive ventilation (facemask settings)

Active Comparator group

Description:

1-hour treatment with facemask noninvasive ventilation (PEEP 5 cmH2O + pressure support 10 cmH2O).

Treatment:

Device: Noninvasive ventilation

Facemask noninvasive ventilation (helmet settings)

Active Comparator group

Description:

1-hour treatment with facemask noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O).

Treatment:

Device: Noninvasive ventilation