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Completed

NCT Number: NCT03237962

High Flow Nasal Cannula During Pulmonary Rehabilitation

The primary purpose of this study is to compare and assess the immediate and long-term effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen therapy device.

The hypotheses was, with high flow nasal cannula usage while exercising, the physiological outcome measurements would be better than conventional oxygen therapy device. Also, the usage of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused by exercising.

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Taoyuan, Taiwan

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About this study

Pulmonary Rehabilitation is one of the most recommended methods to improve the muscle function of COPD patients. By exercise training, even patients with severe COPD can increase muscle strength, improve skeletal muscle function and enhance exercise endurance. Due to improvements in exercise endurance, when exercising at a higher intensity, ventilation support and dynamic hyperinflation would slightly decrease which leads to less dyspnea during exercise. Continuously exercising can also increase the motivation to exercise, reduce mood irritability and psychological burden caused by symptoms. By exercising, patient's health status can be both improved physically and mentally.

High Flow Nasal Cannula (HFNC) is a non-invasive ventilatory device that provides stable oxygen concentration, temperature (37℃) and humidity (Relative Humidity: 100%). Humidity provided by the HFNC reduces irritation caused by the high flow, which leads to the increase of user's tolerance with the device. With the half-closed system formed by a nasal prong, when the high flow enters the upper airway, continue positive airway pressure would be formed.

Subjects enrolled into this study are required to join a 6-week pulmonary rehabilitation program. Before starting the program, subjects were randomly assigned to high flow nasal cannula group and conventional oxygen therapy group. When exercising, the nasal cannula group would receive an oxygen flow of 3 - 5L to maintain SpO2>90% and the HFNC group with high flow setting of 45-50Lpm along with oxygen flow of 3-5L also to maintain SpO2>90%. When joining the pulmonary rehabilitation program, patients are required to exercise for approximately 45 minutes per session. When exercising, changes in the degree of dyspnea, quadriceps blood flow and hemodynamics are assessed. After 6-week of the exercise training, all the parameters will again be assessed and compared to the primary data that was collected from the beginning of the program.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 55 years
  • COPD patients with confirmed pulmonary function test results of FEV1<70%
  • Regular follow-up at the pulmonary medicine clinic
  • Stable condition without acute exacerbation
  • No pulmonary rehabilitation training within a year
  • None oxygen usage at home
  • No smoking history or quit smoking
  • Inform consent signed

Exclusion criteria

  • Fever (Body Temperature >37.5°C)
  • Acute infection symptoms
  • Unstable cardiovascular status (Eg: Blood pressure >150/100 mmHg after medication usage, angina pectoris, or abnormal ECG)
  • Activity restrictions due to orthopedic or neuromuscular disease

Treatment and study plan

High Flow Nasal Cannula

Device

High Flow Nasal Cannula (HFNC) is an oxygen device that increases oxygenation and washes out CO2 within the dead space, it was also clinically used to correct hypoxemia, hypercapnia and respiratory failure.By providing flow rate that is similar to or higher than the patient's inspiratory flow, HFNC is able to provide ventilatory support. To produce stable oxygen concentration, HFNC entrains less air in order to reach the preset value.

Other names: HFNC

Nasal Cannula

Device

Nasal cannula is an oxygen therapy device that has been commonly used as treatment for patients with hypoxemia. With the adjustable flow of 1-6Lpm, the concentration of the oxygen differs as the breathing pattern of the patient changes.

Primary outcomes

  1. Cardiac Output in L/min

    Time frame: Changes from baseline to 6 weeks and 12 weeks

    Heart rate and stroke volume will be combined to report cardiac output in L/min

Secondary outcomes

  1. COPD Assessment Test (CAT)

    Time frame: Changes from baseline to 6 weeks and 12 weeks

    Questionnaire designed to evaluate COPD patient's quality of life.

  2. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: Changes from baseline to 6 weeks and 12 weeks

    Scale to determine the breathlessness of COPD patients during their daily activity

  3. The maximum inspiratory pressure in cmH2O

    Time frame: Changes from baseline to 6 weeks and 12 weeks

    The maximum inspiratory pressure in cmH2O represents the strength of the abdominal and expiratory muscles

  4. The maximum expiratory pressure in cmH2O

    Time frame: Changes from baseline to 6 weeks and 12 weeks

    The maximum expiratory pressure in cmH2O

  5. Tissue Saturation Index

    Time frame: Changes from baseline to 6 weeks and 12 weeks

    Tissue Saturation Index measured by near-Infrared spectroscopy

  6. Total Hemoglobin

    Time frame: Changes from baseline to 6 weeks and 12 weeks

    Total Hemoglobin measured by near-Infrared spectroscopy

  7. Borg Scale

    Time frame: Changes from baseline to 6 weeks and 12 weeks

    Scale examining the level of dyspnea or the shortness of breath during exercise

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Official study title

Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2017
Registry last updated
Feb 25, 2019

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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