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The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804243
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
National Hospital Organization Minami Kyoto Hospital

Brief Summary:
The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Condition or disease Intervention/treatment Phase
Chronic Respiratory Failure Nasal High Flow Therapy Rehabilitation Exercise Endurance Device: nasal high flow therapy Not Applicable

Detailed Description:

In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.

The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
Study Start Date : June 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

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Arm Intervention/treatment
Active Comparator: nasal high flow therapy
In this group, patients have undergone rehabilitation under the nasal high flow therapy (FiO2 100%, oxygen flow from 30 to 60 L/min) during four weeks.
Device: nasal high flow therapy
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.

No Intervention: oxygen therapy
In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks.



Primary Outcome Measures :
  1. Walk distance (measured by six minutes walking test) [ Time Frame: Four weeks ]

Secondary Outcome Measures :
  1. Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.) [ Time Frame: Four weeks ]
  2. Exercise tolerance test (exercise time et.) [ Time Frame: Four weeks ]
  3. Body composition measured by InBody (muscle mass et.) [ Time Frame: Four weeks ]
  4. Arterial blood gas [ Time Frame: Four weeks ]
  5. Inflammation (CRP et.) [ Time Frame: Four weeks ]
  6. Nutritional status (body mass index(kg/m2) et.) [ Time Frame: Four weeks ]
  7. Sympathetic activity (Catecholamine et.) [ Time Frame: Four weeks ]
  8. Dyspnea (Modified Borg scale) [ Time Frame: Four weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.

Exclusion Criteria:

  • Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.
  • Subject who are unable to undergo rehabilitation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804243


Locations
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Japan
National Hospital Organization Minami Kyoto Hospital
Joyo, Kyoto, Japan, 610-0113
Sponsors and Collaborators
National Hospital Organization Minami Kyoto Hospital
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Responsible Party: National Hospital Organization Minami Kyoto Hospital
ClinicalTrials.gov Identifier: NCT02804243    
Other Study ID Numbers: 27-10
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by National Hospital Organization Minami Kyoto Hospital:
nasal high flow therapy
rehabilitation
exercise endurance
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases