NCT01610960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2012

Enrollment Period

4 months

First QC Date

May 24, 2012

Last Update Submit

May 30, 2013

Conditions

Respiratory FailureNon Invasive Ventilation on Healthy Volunteer

Keywords

Non invasive ventilationHelmetNEXT HelmetWork of breathingIntensive care

Outcome Measures

Primary Outcomes (1)

  • 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)

    during the single visit study (day 1)

Secondary Outcomes (3)

  • 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 Arms (2)

HELMET

ACTIVE COMPARATOR

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

Device: Non invasive ventilation HELMET

Facemask

SHAM COMPARATOR

The facemask will be used by each patient.

Device: Non invasive ventilation facemask (Respironics)

Interventions

Non invasive ventilation HELMETDEVICE

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

HELMET
Non invasive ventilation facemask (Respironics)DEVICE

The facemask Respironics (Herrsching, Germany) will be used by each patient.

Facemask

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

Location

Related Publications (1)

  • 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.

    PMID: 24387642DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2012

First Posted

June 4, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 31, 2013

Record last verified: 2012-05

Locations

FR(1)