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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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