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

Primary Purpose

Respiratory Failure, Non Invasive Ventilation on Healthy Volunteer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non invasive ventilation HELMET
Non invasive ventilation facemask (Respironics)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Failure focused on measuring Non invasive ventilation, Helmet, NEXT Helmet, Work of breathing, Intensive care

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

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

Sites / Locations

  • Department of Anesthesiology & Critical Care, St Eloi University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

HELMET

Facemask

Arm Description

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

The facemask will be used by each patient.

Outcomes

Primary Outcome Measures

Work of breathing
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
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
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
The respiratory frequency and current volume will be measured.

Full Information

First Posted
May 24, 2012
Last Updated
May 30, 2013
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01610960
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Non Invasive Ventilation on Healthy Volunteer
Keywords
Non invasive ventilation, Helmet, NEXT Helmet, Work of breathing, Intensive care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HELMET
Arm Type
Active Comparator
Arm Description
The HELMET and HELMET NEXT modes will be tested by each patient.
Arm Title
Facemask
Arm Type
Sham Comparator
Arm Description
The facemask will be used by each patient.
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation HELMET
Intervention Description
The HELMET and HELMET NEXT modes will be tested by each patient.
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation facemask (Respironics)
Intervention Description
The facemask Respironics (Herrsching, Germany) will be used by each patient.
Primary Outcome Measure Information:
Title
Work of breathing
Description
To estimate the work of breathing, we will determine the swings in transdiaphragmatic pressure (Pdi) and the transdiaphragmatic pressure-time product (PTPdi)
Time Frame
during the single visit study (day 1)
Secondary Outcome Measure Information:
Title
Ventilatory comfort
Description
The comfort will be assessed by a self-assessment of the patient on a visual analog scale between 0 (excellent) and 10 (discomfort).
Time Frame
during the single visit study (day 1)
Title
Patient-ventilator asynchronies
Description
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.
Time Frame
during the single visit study (day 1)
Title
Ventilatory parameters
Description
The respiratory frequency and current volume will be measured.
Time Frame
during the single visit study (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Exclusion Criteria: contraindications for nasogastric tube placement Respiratory disease Pregnancy No French health insurance
Facility Information:
Facility Name
Department of Anesthesiology & Critical Care, St Eloi University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24387642
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.
Results Reference
derived

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

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