Efficacy and Mechanism of NIV in Relieving Dyspnea After Exercise in Patients With Stable Severe COPD

NCT03568747 | Completed

• 1 other identifier: GIRD201801
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Exertional dyspnea is a major cause of exercise limitation and anxiety, and contributes importantly to reduced quality of life for patients with COPD. The aim of this study is to determine the efficacy and mechanism of NIV with a dual-limb circuit plus oxygen therapy in relieving exertional dyspnea in patients with severe COPD, so as to provide a guidance for clinical use for NIV.

Conditions

Chronic Obstructive Pulmonary Disease; Dyspnea

Outcome Measures

Primary Outcomes (1)

• change from baseline Borg scale to complete recovery after exercise

  this is a scale that asks the participants to rate the difficulty of breathing. It starts at number 0 where one's breathing is causing no difficulty at all and progresses through to number 10 where one's breathing difficulty is maximal.

  baseline, at peak exercise and at every 30s interval until complete recovery

Secondary Outcomes (2)

• change from baseline diaphragm electromyogram to complete recovery after exercise

  baseline, at peak exercise and at every 30s interval until complete recovery

• change from baseline index of neuromechanical dissociation of the respiratory system to complete recovery after exercise

  baseline, at peak exercise and at every 30s interval until complete recovery

Other Outcomes (14)

• change from baseline transdiaphragmatic pressure to complete recovery after exercise

  baseline, at peak exercise and at every 30s interval until complete recovery

• change from baseline esophageal pressure to complete recovery after exercise

  baseline, at peak exercise and at every 30s interval until complete recovery

• change from baseline mouth pressure to complete recovery after exercise

  baseline, at peak exercise and at every 30s interval until complete recovery

Study Arms (2)

NIV plus oxygen therapy

EXPERIMENTAL

noninvasive ventilation (dual-limb NIV) is given at peak exercise until the borg scale reaches it's baseline point

Device: noninvasive ventilation

oxygen therapy

EXPERIMENTAL

oxygen therapy is given at peak exercise until the borg scale reaches it's baseline point

Device: oxygen therapy

Interventions

noninvasive ventilation DEVICE

dual-limb circuit NIV were given on maquet servo i apparatus

NIV plus oxygen therapy

oxygen therapy DEVICE

oxygen therapy were introduced to the side port of the facemask

oxygen therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe COPD (post bronchodilator FEV1/FVC \< 70% and FEV1 \< 50% predicted)
• stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
• dyspnea as a main symptom that limited daily activities

You may not qualify if:

• obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
• systolic blood pressure \> 160mmHg or diastolic blood pressure \> 100mmHg at rest
• unstable angina or a myocardial infarct in the previous four weeks
• resting sinus tachycardia ( \> 120 beats/min)
• patients with musculoskeletal or neurological disorders
• patients who are unable to give informed consent

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Noninvasive Ventilation; Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Rongchang Chen

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 26, 2018
• Study Start: June 23, 2018
• Primary Completion: February 3, 2019
• Study Completion: April 30, 2019
• Last Updated: July 30, 2019

Record last verified: 2018-06

Locations

CN (1)