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Clinical Trials/NCT01610960
NCT01610960
Completed
Not Applicable

Comparison of Helmet NEXT, Helmet Standard and Facemask for Noninvasive Ventilation: a Physiological Study in Healthy Volunteers

University Hospital, Montpellier1 site in 1 country13 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
University Hospital, Montpellier
Enrollment
13
Locations
1
Primary Endpoint
Work of breathing
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
August 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers

Exclusion Criteria

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

Outcomes

Primary Outcomes

Work of breathing

Time Frame: during the single visit study (day 1)

To estimate the work of breathing, we will determine the swings in transdiaphragmatic pressure (Pdi) and the transdiaphragmatic pressure-time product (PTPdi)

Secondary Outcomes

  • Ventilatory comfort(during the single visit study (day 1))
  • Patient-ventilator asynchronies(during the single visit study (day 1))
  • Ventilatory parameters(during the single visit study (day 1))

Study Sites (1)

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