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

Primary Purpose

Dyspnea, Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Optiflow with an inspired fraction of oxygen of 100%
Optiflow with an inspired fraction of oxygen of 21%
Sponsored by
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspnea focused on measuring Dyspnea, High flow nasal cannula

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

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

Sites / Locations

  • Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
  • Service de Pneumologie et Réanimation Médicale

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oxygen first

Air first

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effects of high flow nasal cannula on strapping induced type of dyspnea
Evaluated by visual annylogic scale

Secondary Outcome Measures

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
Evaluated by visual annylogic scale

Full Information

First Posted
February 25, 2018
Last Updated
February 14, 2019
Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
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1. Study Identification

Unique Protocol Identification Number
NCT03469037
Brief Title
Effects on Experimental Dyspnea of High Flow Nasal Cannula
Acronym
EDEN
Official Title
Effects on an Experimental Dyspnea by Thoraco-abdominal Elastic Strapping of the High Flow Nasal Cannula
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Healthy Volunteers
Keywords
Dyspnea, High flow nasal cannula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxygen first
Arm Type
Experimental
Arm Description
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
Arm Title
Air first
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Optiflow with an inspired fraction of oxygen of 100%
Other Intervention Name(s)
High flow nasal cannula with oxygen added
Intervention Description
Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 100%
Intervention Type
Device
Intervention Name(s)
Optiflow with an inspired fraction of oxygen of 21%
Other Intervention Name(s)
High flow nasal cannula without oxygen added
Intervention Description
Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 21%
Primary Outcome Measure Information:
Title
Effects of high flow nasal cannula on strapping induced type of dyspnea
Description
Evaluated by visual annylogic scale
Time Frame
One hour
Secondary Outcome Measure Information:
Title
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
Description
Evaluated by visual annylogic scale
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Exclusion Criteria: chronic pathology active smokers anxiety disorder allergy to latex protected adult woman declared herself pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Capucine Morelot-Panzini, Doctor
Organizational Affiliation
Service de Pneumologie de la Pitié-Salpétrière
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Similowski, PHD
Organizational Affiliation
Service de Pneumologie de la Pitié-Salpétrière
Official's Role
Study Director
Facility Information:
Facility Name
Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Service de Pneumologie et Réanimation Médicale
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects on Experimental Dyspnea of High Flow Nasal Cannula

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