Clinical trial NCT01610960: Comparison of Three Noninvasive Ventilation Modes: a Physiological Study in Healthy Volunteers
Official title: Comparison of Helmet NEXT, Helmet Standard and Facemask for Noninvasive Ventilation: a Physiological Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Non Invasive Ventilation on Healthy Volunteer
Keywords: Non invasive ventilation
Helmet
NEXT Helmet
Work of breathing
Intensive care
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

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

Primary outcomes:
measure: Work of breathing
timeFrame: during the single visit study (day 1)
Secondary outcomes:
measure: Ventilatory comfort
timeFrame: during the single visit study (day 1)
measure: Patient-ventilator asynchronies
timeFrame: during the single visit study (day 1)
measure: Ventilatory parameters
timeFrame: during the single visit study (day 1)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital
Study officials:
References:
citation: Vaschetto R, De Jong A, Conseil M, Galia F, Mahul M, Coisel Y, Prades A, Navalesi P, Jaber S. Comparative evaluation of three interfaces for non-invasive ventilation: a randomized cross-over design physiologic study on healthy volunteers. Crit Care. 2014 Jan 3;18(1):R2. doi: 10.1186/cc13175.