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

This study is currently recruiting participants.
Verified May 2012 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01610960
First received: May 24, 2012
Last updated: June 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Respiratory Failure
Non Invasive Ventilation on Healthy Volunteer
 Device: Non invasive ventilation HELMET
Device: Non invasive ventilation facemask (Respironics)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Helmet NEXT, Helmet Standard and Facemask for Noninvasive Ventilation: a Physiological Study in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 16
Study Start Date: April 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HELMET
The HELMET and HELMET NEXT modes will be tested by each patient.
 Device: Non invasive ventilation HELMET
The HELMET and HELMET NEXT modes will be tested by each patient.
Sham Comparator: Facemask
The facemask will be used by each patient.
 Device: Non invasive ventilation facemask (Respironics)
The facemask Respironics (Herrsching, Germany) will be used by each patient.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • contraindications for nasogastric tube placement
  • Respiratory disease
  • Pregnancy
  • No French health insurance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610960

Contacts
Contact: Samir Jaber, MD PhD + 33 4 67 33 72 71 s-jaber@chu-montpellier.fr

Locations
France
Department of Anesthesiology & Critical Care, St Eloi University Hospital Recruiting
Montpellier, France, 34000
Contact: Samir Jaber, MD PhD     + 33 4 67 33 72 71     s-jaber@chu-montpellier.fr    
Principal Investigator: Samir Jaber, MD PhD            
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01610960     History of Changes
Other Study ID Numbers: 8937
Study First Received: May 24, 2012
Last Updated: June 1, 2012
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
Non invasive ventilation
Helmet
NEXT Helmet
Work of breathing
Intensive care

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013