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CompletedNCT03469037EDENUpdated Feb 15, 2019

Effects on Experimental Dyspnea of High Flow Nasal Cannula

An interventional study of Optiflow with an inspired fraction of oxygen of 100% and Optiflow with an inspired fraction of oxygen of 21% in Dyspnea and Healthy Volunteers, sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil. Completed at 2 sites in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Dyspnea
  • Healthy Volunteers

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Keywords

  • Dyspnea, High flow nasal cannula
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

Exclusion Criteria:

  • chronic pathology
  • active smokers
  • anxiety disorder
  • allergy to latex
  • protected adult
  • woman declared herself pregnant
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • 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% · Device: Optiflow with an inspired fraction of oxygen of 21%

  • 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% · Device: Optiflow with an inspired fraction of oxygen of 21%

Interventions

  • DeviceOptiflow with an inspired fraction of oxygen of 100%

    Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 100%

    Also known as: High flow nasal cannula with oxygen added

  • DeviceOptiflow with an inspired fraction of oxygen of 21%

    Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 21%

    Also known as: High flow nasal cannula without oxygen added

05

What researchers measure

Primary outcomes

  1. Effects of high flow nasal cannula on strapping induced type of dyspnea

    Evaluated by visual annylogic scale

    Time frame: One hour

Secondary outcomes

  1. 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

    Time frame: One hour

06

Study locations

2 sites
  • Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
    Paris, 75013, France
  • Service de Pneumologie et Réanimation Médicale
    Paris, 75013, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03469037
Lead sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Responsible party
Sponsor
First posted
Mar 19, 2018
Start date
May 22, 2018
Primary completion
Nov 2, 2018
Completion
Nov 2, 2018
Last update
Feb 15, 2019

Study contacts

Capucine Morelot-Panzini, Doctor
principal investigator · Service de Pneumologie de la Pitié-Salpétrière
Thomas Similowski, PHD
study director · Service de Pneumologie de la Pitié-Salpétrière

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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