Comparison of Three Noninvasive Ventilation Modes: a Physiological Study in Healthy Volunteers

University Hospital Center (CHU)

Status: Completed

Conditions: Respiratory Failure; Non Invasive Ventilation on Healthy Volunteer

Treatments: Device: Non invasive ventilation facemask (Respironics); Device: Non invasive ventilation HELMET

Study type: Interventional

Funder types: Other

Identifiers

NCT01610960

8937

Details and patient eligibility

About

Noninvasive ventilation (NIV) is a well established, safe, and effective technique in improving gas exchange while reducing dyspnea and inspiratory effort in patients with either hypoxemic and hypercapnic acute respiratory failure (ARF) and averts the risk secondary to endotracheal intubation.Crucial factors for NIV success, in any forms of respiratory failure, are the tolerance to the interface used and the ability of the interface to unload inspiratory-muscle. Helmet is better tolerated over time, allowing continuous application of NIV for longer periods, while face mask has been proved to be more efficient at iso-support in unloading the respiratory muscles and improving patient-ventilator synchrony. Helmet NEXT (CaStar, NIV model, Starmed, Mirandola, Italy) is a novel type of helmet with a better compliant wall, that avoid the use of armpit braces potentially improving, compared to the standard helmet, both pressurization and patient-ventilator interaction and tolerance. The objective of this study is to compare the effects of NIV delivered via face mask, standard helmet, and NEXT helmet in terms of work of breathing, patient-ventilator interaction, and comfort.

Full description

16 Healthy volunteers will be enrolled. They will be ventilated with non invasive ventilation. The Work of breathing, ventilator/patient asynchrony, and ventilatory comfort produced between face mask, Helmet and NEXT helmet will be compared.

Enrollment: 13 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

• contraindications for nasogastric tube placement
• Respiratory disease
• Pregnancy
• No French health insurance

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

HELMET

Active Comparator group

Description:

The HELMET and HELMET NEXT modes will be tested by each patient.

Treatment:

Device: Non invasive ventilation HELMET

Facemask

Sham Comparator group

Description:

The facemask will be used by each patient.

Treatment:

Device: Non invasive ventilation facemask (Respironics)