DyspneaEDENNCT03469037
Effects on Experimental Dyspnea of High Flow Nasal Cannula
A study testing Optiflow with an inspired fraction of oxygen of 100% and Optiflow with an inspired fraction of oxygen of 21% in people with Dyspnea and Healthy Volunteers, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspnea, Healthy Volunteers
- What is being tested?
- Optiflow with an inspired fraction of oxygen of 100% and Optiflow with an inspired fraction of oxygen of 21%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- 22 May 2018to 2 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- chronic pathology
- active smokers
- anxiety disorder
- allergy to latex
- protected adult
- woman declared herself pregnant
Trial locations and contacts
2 sites in 1 country.
France2 sites
Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
Paris, 75013
Service de Pneumologie et Réanimation Médicale
Paris, 75013
About this study
Official title: 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).
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.
- Conditions
- Dyspnea, Healthy Volunteers
- Being tested
- Optiflow with an inspired fraction of oxygen of 100%, Optiflow with an inspired fraction of oxygen of 21%
- Keywords
- Dyspnea, High flow nasal cannula
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow with an inspired fraction of oxygen of 100%Device
Also called High flow nasal cannula with oxygen added
Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 100%
Optiflow with an inspired fraction of oxygen of 21%Device
Also called High flow nasal cannula without oxygen added
Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 21%
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Optiflow with an inspired fraction of oxygen of 100%; Device: Optiflow with an inspired fraction of oxygen of 21% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of high flow nasal cannula on strapping induced type of dyspnea
Evaluated by visual annylogic scale
Measured: 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
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start22 May 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Capucine Morelot-Panzini, Doctor, Principal investigator, Service de Pneumologie de la Pitié-SalpétrièreThomas Similowski, PHD, Study director, Service de Pneumologie de la Pitié-Salpétrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469037
- Sponsor's protocol ID
- 2018-A00178- 47
- Acronym
- EDEN
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on an Experimental Dyspnea by Thoraco-abdominal Elastic Strapping of the High Flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT03469037
- Acronym / sponsor ID
- EDEN / 2018-A00178- 47
- Conditions
- Dyspnea, Healthy Volunteers
- Keywords
- Dyspnea, High flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen first | Experimental | Device: Optiflow with an inspired fraction of oxygen of 100%, Device: Optiflow with an inspired fraction of oxygen of 21%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 |
| Air first | Experimental | Device: Optiflow with an inspired fraction of oxygen of 100%, Device: Optiflow with an inspired fraction of oxygen of 21%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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (6 listed)
- chronic pathology
- active smokers
- anxiety disorder
- allergy to latex
- protected adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optiflow with an inspired fraction of oxygen of 100%Also: High flow nasal cannula with oxygen addedRespiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 100% | Device | Air first, Oxygen first |
| Optiflow with an inspired fraction of oxygen of 21%Also: High flow nasal cannula without oxygen addedRespiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 21% | Device | Air first, Oxygen first |
Primary outcome
Effects of high flow nasal cannula on strapping induced type of dyspnea
Time frame: One hour
Evaluated by visual annylogic scale
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow with an inspired fraction of oxygen of 100% and Optiflow with an inspired fraction of oxygen of 21% in people with Dyspnea and Healthy Volunteers, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of high flow nasal cannula on strapping induced type of dyspnea (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.