Effects on Experimental Dyspnea of High Flow Nasal Cannula (EDEN)

February 14, 2019 updated by: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Effects on an Experimental Dyspnea by Thoraco-abdominal Elastic Strapping of the High Flow Nasal Cannula

To develop an experimental model of dyspnea by external thoraco-abdominal elastic strapping at rest in order to study the mechanisms involved in the relief of dyspnea by the administration of high flow by nasal cannula (HFNC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will measure the effect of HFNC on an experimental model of dyspnea induced by thoraco-abdominal elastic strapping on healthy subjects at rest.

The study will also compare the effects on dyspnea of the administration of high flow nasal cannula with and without oxygen added.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
      • Paris, France, 75013
        • Service de Pneumologie et Réanimation Médicale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • chronic pathology
  • active smokers
  • anxiety disorder
  • allergy to latex
  • protected adult
  • woman declared herself pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxygen first
Optiflow with an inspired fraction of oxygen of 100% in the first seance Optiflow with an inspired fraction of oxygen of 21 % in the second seance
Device: Optiflow with an inspired fraction of oxygen of 100%
Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 100%
Other Names:
  • High flow nasal cannula with oxygen added
Device: Optiflow with an inspired fraction of oxygen of 21%
Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 21%
Other Names:
  • High flow nasal cannula without oxygen added
Experimental: Air first
Optiflow with an inspired fraction of oxygen of 21 % in the first seance Optiflow with an inspired fraction of oxygen of 100 % in the second seance
Device: Optiflow with an inspired fraction of oxygen of 100%
Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 100%
Other Names:
  • High flow nasal cannula with oxygen added
Device: Optiflow with an inspired fraction of oxygen of 21%
Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 21%
Other Names:
  • High flow nasal cannula without oxygen added

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of high flow nasal cannula on strapping induced type of dyspnea
Time Frame: One hour
Evaluated by visual annylogic scale
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the effect of the high flow by nasal cannula with and without oxygen on an experimental dyspnea, evaluated by the differences of changes in the visual analogic scale
Time Frame: One hour
Evaluated by visual annylogic scale
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Investigators

  • Principal Investigator: Capucine Morelot-Panzini, Doctor, Service de Pneumologie de la Pitié-Salpétrière
  • Study Director: Thomas Similowski, PHD, Service de Pneumologie de la Pitié-Salpétrière

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Actual)

November 2, 2018

Study Completion (Actual)

November 2, 2018

Study Registration Dates

First Submitted

February 25, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A00178- 47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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