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NCT Number: NCT03423888

High-flow Nasal Oxygen 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.

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Key information

Conditions

Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital LARREY, CHU Toulouse

Toulouse, 31059, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Acceptability of High-flow Nasal Oxygen to Relieve Dyspnea in Palliative Care: Pilot Study

Acronym: OXYPALL

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2018
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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