DyspneaOXYPALLNCT03423888
High-flow Nasal Oxygen in Palliative Care: Pilot Study
A study testing high-flow nasal cannula oxygen therapy (HNFC) in people with Dyspnea, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In palliative care, the relief of the dyspnea is necessary. Medications for the reduction of dyspnea have side effects. High-flow nasal cannula oxygen therapy (HFNC) is a new way to deliver oxygen. Investigators hypothesize that HNFC is an acceptable technic for the patient with dyspnea in palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- high-flow nasal cannula oxygen therapy (HNFC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to 25 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient followed for respiratory failure with palliative care and :
- More than 18 years old
- Dyspnea related to a respiratory disease
- Hypoxemia requiring the introduction of more than 4 liters of oxygen for a sp02 > 90%
- Patient affiliated to a social security system
Who cannot join
- Patient less than 18 years old
- Patient with guardianship, trusteeship
- No consent for participation at the study
- Project of curative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability of High-flow Nasal Oxygen to Relieve Dyspnea in Palliative Care: Pilot Study
In palliative care, the relief of the dyspnea is necessary. Medications for the reduction of dyspnea have side effects. High-flow nasal cannula oxygen therapy (HFNC) is a new way to deliver oxygen. Investigators hypothesize that HNFC is an acceptable technic for the patient with dyspnea in palliative care.
A pilot study with 30 patients will be conducted. Acceptability of HNFC will be studied by the time of use by patients of the HNFC during one week. The effectiveness of HNFC in relieving dyspnea will be studied using Borg scale.
Read the detailed description
Pilot study for acceptability of high flow nasal cannula oxygen therapy in palliative care Population: 30 patients in palliative care (for lung cancer, terminal respiratory failure) who suffer from dyspnea and have oxygen therapy. Patients with curative care are excluded and patients who require non invasive ventilation.
An oral consent is asked.
Primary objective: acceptability of HNFC in patients with dyspnea in palliative care during one week
Secondary objectives:
- Tolerance of HNFC at short term (1h and 24h) and long term (7 days) after initiation of HNFC
- Efficiency of HNFC at short term
Primary outcome: duration of use of the HNFC during 7 days
Secondary outcome:
- Tolerance: noise of the system of HNFC, side effects of high flow (nasal dryness..)
- Efficiency: evaluation of dyspnea by Borg scale and measure of respiratory rate and saturation of oxygen one hour after initiation of HNFC
- Conditions
- Dyspnea
- Being tested
- high-flow nasal cannula oxygen therapy (HNFC)
- Keywords
- Dyspnea, palliative care, high-flow nasal oxygen, pilot study
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flow nasal cannula oxygen therapy (HNFC)Device
Set up of high-flow nasal oxygen for patient with dyspnea for a respiratory disease without possibility of curative care. Patients who require a treatment by oxygen are included.
After 7 days of treatment, acceptability is evaluated by the duration of use of HNFC.
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal oxygen | Experimental | Not described Receives: Device: high-flow nasal cannula oxygen therapy (HNFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of HNFC in patients with dyspnea in palliative care during one week
Duration of use of HNFC: nurses will set up the device to the patient who can withdraw it at any time. It will then be noted the stop time and recovery of the device for a week, which will know the time of use and acceptability. If the patient wishes to permanently stop the use of the device, the stop time will be raised.
Measured: 7 days
Secondary outcomes (3)
Efficiency of high-flow nasal oxygen in palliative care with dyspnea
Evaluation of dyspnea with the Borg scale. The Borg scale is a scale containing 10 proposals ranging in increasing order of severity (from no gene at all to extremely embarrassed) that will allow the patient to grading his respiratory gene.
Measured: At short term: one hour after the initiation and at long term: 24h and seven days after the start
Efficiency of high-flow nasal oxygen in palliative care with Sp02
Evaluation of Sp02 using transcutaneous oximeter
Measured: At short term: one hour after the initiation and at long term: 24h and seven days after the start
Efficiency of high-flow nasal oxygen in palliative care with respiratory rate
Evaluation of respiratory rate
Measured: At short term: one hour after the initiation and at long term: 24h and seven days after the start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start13 Feb 2018
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion DUPUIS, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423888
- Sponsor's protocol ID
- RC31/17/0351
- Other IDs
- 2017-A03377-46
- Acronym
- OXYPALL
- Status last verified
- Apr 2022
- First submitted
- 26 Jan 2018
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of High-flow Nasal Oxygen to Relieve Dyspnea in Palliative Care: Pilot Study
- ClinicalTrials.gov ID
- NCT03423888
- Acronym / sponsor ID
- OXYPALL / RC31/17/0351
- Conditions
- Dyspnea
- Keywords
- Dyspnea, palliative care, high-flow nasal oxygen, pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 6 Feb 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.
In palliative care, the relief of the dyspnea is necessary. Medications for the reduction of dyspnea have side effects. High-flow nasal cannula oxygen therapy (HFNC) is a new way to deliver oxygen. Investigators hypothesize that HNFC is an acceptable technic for the patient with dyspnea in palliative care.
A pilot study with 30 patients will be conducted. Acceptability of HNFC will be studied by the time of use by patients of the HNFC during one week. The effectiveness of HNFC in relieving dyspnea will be studied using Borg scale.
Detailed description
Pilot study for acceptability of high flow nasal cannula oxygen therapy in palliative care Population: 30 patients in palliative care (for lung cancer, terminal respiratory failure) who suffer from dyspnea and have oxygen therapy. Patients with curative care are excluded and patients who require non invasive ventilation.
An oral consent is asked.
Primary objective: acceptability of HNFC in patients with dyspnea in palliative care during one week
Secondary objectives:
- Tolerance of HNFC at short term (1h and 24h) and long term (7 days) after initiation of HNFC
- Efficiency of HNFC at short term
Primary outcome: duration of use of the HNFC during 7 days
Secondary outcome:
- Tolerance: noise of the system of HNFC, side effects of high flow (nasal dryness..)
- Efficiency: evaluation of dyspnea by Borg scale and measure of respiratory rate and saturation of oxygen one hour after initiation of HNFC
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal oxygen | Experimental | Device: high-flow nasal cannula oxygen therapy (HNFC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient followed for respiratory failure with palliative care and :
- More than 18 years old
- Dyspnea related to a respiratory disease
- Hypoxemia requiring the introduction of more than 4 liters of oxygen for a sp02 > 90%
- Patient affiliated to a social security system
Key exclusion criteria (4 listed)
- Patient less than 18 years old
- Patient with guardianship, trusteeship
- No consent for participation at the study
- Project of curative care
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 |
|---|---|---|
| high-flow nasal cannula oxygen therapy (HNFC)Set up of high-flow nasal oxygen for patient with dyspnea for a respiratory disease without possibility of curative care. Patients who require a treatment by oxygen are included. After 7 days of treatment, acceptability is evaluated by the duration of use of HNFC. | Device | High-flow nasal oxygen |
Primary outcome
Acceptability of HNFC in patients with dyspnea in palliative care during one week
Time frame: 7 days
Duration of use of HNFC: nurses will set up the device to the patient who can withdraw it at any time. It will then be noted the stop time and recovery of the device for a week, which will know the time of use and acceptability. If the patient wishes to permanently stop the use of the device, the stop time will be raised.
3 secondary outcomes
Efficiency of high-flow nasal oxygen in palliative care with dyspnea
Time frame: At short term: one hour after the initiation and at long term: 24h and seven days after the start
Efficiency of high-flow nasal oxygen in palliative care with Sp02
Time frame: At short term: one hour after the initiation and at long term: 24h and seven days after the start
Efficiency of high-flow nasal oxygen in palliative care with respiratory rate
Time frame: At short term: one hour after the initiation and at long term: 24h and seven days after the start
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 14 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Dyspnea
Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Recruiting
The Effects of Wintergreen Essential Oil Inhalation on Alleviating Dyspnea Among Patients With Pneumonia
Pneumonia, Dyspnea
Not yet recruiting
Visual and Auditory Stimulation in Intensive Care Patients
Dyspnea, Sleep Quality
Recruiting
Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer.
Lung Neoplasms, Thoracic Surgery Lung
Recruiting
The Increase of Lung Capacity Using the Lung Master (Pulmonary Exerciser)
Dyspnea, Chronic Obstructive Pulmonary Disease
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.
Marion DUPUIS, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-flow nasal cannula oxygen therapy (HNFC) in people with Dyspnea, run by University Hospital, Toulouse at 1 site 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 5 inclusion and 4 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Acceptability of HNFC in patients with dyspnea in palliative care during one week (time frame: 7 days). 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 14 Apr 2022.