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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01610960
First received: May 24, 2012
Last updated: May 30, 2013
Last verified: May 2012

May 24, 2012
May 30, 2013
April 2012
August 2012   (final data collection date for primary outcome measure)
Work of breathing [ Time Frame: during the single visit study (day 1) ] [ Designated as safety issue: No ]
To estimate the work of breathing, we will determine the swings in transdiaphragmatic pressure (Pdi) and the transdiaphragmatic pressure-time product (PTPdi)
Same as current
Complete list of historical versions of study NCT01610960 on ClinicalTrials.gov Archive Site
  • Ventilatory comfort [ Time Frame: during the single visit study (day 1) ] [ Designated as safety issue: No ]
    The comfort will be assessed by a self-assessment of the patient on a visual analog scale between 0 (excellent) and 10 (discomfort).
  • Patient-ventilator asynchronies [ Time Frame: during the single visit study (day 1) ] [ Designated as safety issue: No ]
    The patient-ventilator asynchronies will be assessed by the asynchronie index (number of asynchronies / number of respiratory cycles). The number of asynchronies will be assessed by the investigator, on the records of the pression curves and the respiratory outputs.
  • Ventilatory parameters [ Time Frame: during the single visit study (day 1) ] [ Designated as safety issue: No ]
    The respiratory frequency and current volume will be measured.
Same as current
Not Provided
Not Provided
 
Comparison of Three Noninvasive Ventilation Modes: a Physiological Study in Healthy Volunteers
Comparison of Helmet NEXT, Helmet Standard and Facemask for Noninvasive Ventilation: a Physiological Study in Healthy Volunteers

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Respiratory Failure
  • Non Invasive Ventilation on Healthy Volunteer
  • Device: Non invasive ventilation HELMET
    The HELMET and HELMET NEXT modes will be tested by each patient.
  • Device: Non invasive ventilation facemask (Respironics)
    The facemask Respironics (Herrsching, Germany) will be used by each patient.
  • Active Comparator: HELMET
    The HELMET and HELMET NEXT modes will be tested by each patient.
    Intervention: Device: Non invasive ventilation HELMET
  • Sham Comparator: Facemask
    The facemask will be used by each patient.
    Intervention: Device: Non invasive ventilation facemask (Respironics)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • contraindications for nasogastric tube placement
  • Respiratory disease
  • Pregnancy
  • No French health insurance
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01610960
8937
No
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Not Provided
University Hospital, Montpellier
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP