NCT03423888

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 26, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

January 26, 2018

Last Update Submit

April 13, 2022

Conditions

Keywords

Dyspneapalliative carehigh-flow nasal oxygenpilot study

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Secondary Outcomes (3)

  • Efficiency of high-flow nasal oxygen in palliative care with dyspnea

    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

    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

    At short term: one hour after the initiation and at long term: 24h and seven days after the start

Other Outcomes (1)

  • Tolerance of high-flow nasal oxygen in palliative care

    At short term: one hour after the initiation and at long term: 24h and seven days after the start

Study Arms (1)

High-flow nasal oxygen

EXPERIMENTAL
Device: high-flow nasal cannula oxygen therapy (HNFC)

Interventions

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.

High-flow nasal oxygen

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Patient less than 18 years old
  • Patient with guardianship, trusteeship
  • No consent for participation at the study
  • Project of curative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital LARREY, CHU Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marion DUPUIS, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 6, 2018

Study Start

February 13, 2018

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations