Physiology of Helmet vs. Facemask Noninvasive Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-19

Study Completion Date

2025-09-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Acute Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Helmet noninvasive ventilation

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

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type DEVICE

noninvasive ventilation

Facemask noninvasive ventilation (facemask settings)

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

Group Type ACTIVE_COMPARATOR

Noninvasive ventilation

Intervention Type DEVICE

noninvasive ventilation

Facemask noninvasive ventilation (helmet settings)

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

Group Type ACTIVE_COMPARATOR

Noninvasive ventilation

Intervention Type DEVICE

noninvasive ventilation

Interventions

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Noninvasive ventilation

noninvasive ventilation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No