High-flow Nasal Oxygen in Palliative Care: Pilot Study (OXYPALL)
Primary Purpose
Dyspnea
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high-flow nasal cannula oxygen therapy (HNFC)
Sponsored by
About this trial
This is an interventional supportive care trial for Dyspnea focused on measuring Dyspnea, palliative care, high-flow nasal oxygen, pilot study
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient less than 18 years old
- Patient with guardianship, trusteeship
- No consent for participation at the study
- Project of curative care
Sites / Locations
- Hospital LARREY, CHU Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High-flow nasal oxygen
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Efficiency of high-flow nasal oxygen in palliative care with Sp02
Evaluation of Sp02 using transcutaneous oximeter
Efficiency of high-flow nasal oxygen in palliative care with respiratory rate
Evaluation of respiratory rate
Full Information
NCT ID
NCT03423888
First Posted
January 26, 2018
Last Updated
April 13, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03423888
Brief Title
High-flow Nasal Oxygen in Palliative Care: Pilot Study
Acronym
OXYPALL
Official Title
Acceptability of High-flow Nasal Oxygen to Relieve Dyspnea in Palliative Care: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Dyspnea, palliative care, high-flow nasal oxygen, pilot study
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-flow nasal oxygen
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
high-flow nasal cannula oxygen therapy (HNFC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of HNFC in patients with dyspnea in palliative care during one week
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Efficiency of high-flow nasal oxygen in palliative care with dyspnea
Description
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.
Time Frame
At short term: one hour after the initiation and at long term: 24h and seven days after the start
Title
Efficiency of high-flow nasal oxygen in palliative care with Sp02
Description
Evaluation of Sp02 using transcutaneous oximeter
Time Frame
At short term: one hour after the initiation and at long term: 24h and seven days after the start
Title
Efficiency of high-flow nasal oxygen in palliative care with respiratory rate
Description
Evaluation of respiratory rate
Time Frame
At short term: one hour after the initiation and at long term: 24h and seven days after the start
Other Pre-specified Outcome Measures:
Title
Tolerance of high-flow nasal oxygen in palliative care
Description
Side effects (nasal dryness, nasal lesion) and noise with an numerical scale graduated from 0 to 10 (0 for no noise to 10 very noisy)
Time Frame
At short term: one hour after the initiation and at long term: 24h and seven days after the start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patient less than 18 years old
Patient with guardianship, trusteeship
No consent for participation at the study
Project of curative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion DUPUIS, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital LARREY, CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High-flow Nasal Oxygen in Palliative Care: Pilot Study
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