High-flow Nasal Oxygen in Palliative Care: Pilot Study (OXYPALL)

April 13, 2022 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Hospital LARREY, CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-flow nasal oxygen
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
Evaluation of Sp02 using transcutaneous oximeter
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
Evaluation of respiratory rate
At short term: one hour after the initiation and at long term: 24h and seven days after the start

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance of high-flow nasal oxygen in palliative care
Time Frame: At short term: one hour after the initiation and at long term: 24h and seven days after the start
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)
At short term: one hour after the initiation and at long term: 24h and seven days after the start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Marion Dupuis, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2018

Primary Completion (Actual)

January 25, 2022

Study Completion (Actual)

January 25, 2022

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/17/0351
  • 2017-A03377-46 (Other Identifier: Id-RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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