NCT03469037

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

February 25, 2018

Last Update Submit

February 14, 2019

Conditions

DyspneaHealthy Volunteers

Keywords

Dyspnea, High flow nasal cannula

Outcome Measures

Primary Outcomes (1)

  • Effects of high flow nasal cannula on strapping induced type of dyspnea

    Evaluated by visual annylogic scale

    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

    One hour

Study Arms (2)

Oxygen first

EXPERIMENTAL

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%

Air first

EXPERIMENTAL

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

Optiflow with an inspired fraction of oxygen of 100%DEVICE

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
Air firstOxygen first
Optiflow with an inspired fraction of oxygen of 21%DEVICE

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
Air firstOxygen first

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation

Paris, 75013, France

Location

Service de Pneumologie et Réanimation Médicale

Paris, 75013, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Capucine Morelot-Panzini, Doctor

    Service de Pneumologie de la Pitié-Salpétrière

    PRINCIPAL INVESTIGATOR

  • Thomas Similowski, PHD

    Service de Pneumologie de la Pitié-Salpétrière

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2018

First Posted

March 19, 2018

Study Start

May 22, 2018

Primary Completion

November 2, 2018

Study Completion

November 2, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)