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

NCT ID: NCT01610960

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Respiratory Failure Non Invasive Ventilation on Healthy Volunteer

Keywords

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Non invasive ventilation Helmet NEXT Helmet Work of breathing Intensive care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HELMET

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

Group Type ACTIVE_COMPARATOR

Non invasive ventilation HELMET

Intervention Type DEVICE

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

Facemask

The facemask will be used by each patient.

Group Type SHAM_COMPARATOR

Non invasive ventilation facemask (Respironics)

Intervention Type DEVICE

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

Interventions

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Non invasive ventilation HELMET

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

Intervention Type DEVICE

Non invasive ventilation facemask (Respironics)

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers

Exclusion Criteria

* contraindications for nasogastric tube placement
* Respiratory disease
* Pregnancy
* No French health insurance
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 24387642 (View on PubMed)

Other Identifiers

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8937

Identifier Type: -

Identifier Source: org_study_id