Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03568747
Other study ID # GIRD201801
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 23, 2018
Est. completion date April 30, 2019

Study information

Verified date June 2018
Source Guangzhou Institute of Respiratory Disease
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Exertional dyspnea was the most characteristic respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD), it is a major cause of exercise limitation and anxiety, and contributes importantly to reduced quality of life for patients with COPD. COPD patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea. The sedentarism results in physical deconditioning and alterations of the peripheral muscles, which leads to a vicious circle and contribute to the debilitation of the patients. Thereby, intervention should be taken to intervene this vicious cycle. It has been reported that noninvasive ventilation (NIV) could help unload the inspiratory muscle, improve dynamic pulmonary hyperinflation, improve neuro-mechanical coupling, oxygenation, and thus relieved dyspnea during exercise in COPD patients. However, in these reports, NIV was used as add-on therapy during exercise or at resting condition before exertional dyspnea occurred. So far, there's few studies on the efficacy of NIV used at the time of exertional dyspnea occurred as the rescue therapy to relieve dyspnea after exercise in patients with stable severe COPD while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication, which might relieve their physiological and perceptional burden to limit their activities. The result of the investigators previous study has suggested that compared with oxygen therapy, NIV plus oxygen therapy resulted in decrease in dyspnea intensity at isotime, however, there's no statistically significant shortening in total dyspnea recovery time and NIV was not helpful in all the COPD patients. In another study, it was indicated that ventilated by a single-limb tubing with a plateau exhalation valve (PEV) caused CO2 rebreathing to COPD patients during exercise. CO2 rebreathing may have a negative impact on efficacy. Previous studies have proved that exercise tolerance was improved ventilated by noninvasive ventilation with a dual-limb circuit. In theory, NIV with a dual-limb circuit consists of one inhalation limb that introduces air into the patient's airways and one exhalation limb that leads exhaled gas outside of the airways, there is no risk of rebreathing. However, it is unclear whether NIV with a dual-limb circuit could be used at the time of exertional dyspnea occurred as rescue therapy to relieve dyspnea after exercise in patients with stable severe COPD and what are the mechanisms. The purpose of this study was therefore to determine whether assisted with NIV with dual-limb circuit in patients with stable severe COPD after exercise with exertional dyspnea (1)dyspnea was relieved after exercise in patients with stable severe COPD; (2)the repiratory mechanism.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 30, 2019
Est. primary completion date February 3, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
noninvasive ventilation
dual-limb circuit NIV were given on maquet servo i apparatus
oxygen therapy
oxygen therapy were introduced to the side port of the facemask

Locations

Country Name City State
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other change from baseline transdiaphragmatic pressure to complete recovery after exercise Pdi baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline esophageal pressure to complete recovery after exercise Pes baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline mouth pressure to complete recovery after exercise Pm baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline inspiratory capacity to complete recovery after exercise IC baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline minute ventilation to complete recovery after exercise VE baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline oxygen saturation to complete recovery after exercise SpO2 baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline heart rate to complete recovery after exercise HR baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline total recovery time to complete recovery after exercise total recovery time baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline tidal volume to complete recovery after exercise Vt baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline respiratory rate to complete recovery after exercise RR baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline inspiratory time to complete recovery after exercise Ti baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline total duty cycle to complete recovery after exercise Ttot baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline expiratory time to complete recovery after exercise Te baseline, at peak exercise and at every 30s interval until complete recovery
Other change from baseline pressure time product to complete recovery after exercise PTP baseline, at peak exercise and at every 30s interval until complete recovery
Primary 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 change from baseline diaphragm electromyogram to complete recovery after exercise EMGdi baseline, at peak exercise and at every 30s interval until complete recovery
Secondary change from baseline index of neuromechanical dissociation of the respiratory system to complete recovery after exercise EMGdi%max:Vt%VCpred baseline, at peak exercise and at every 30s interval until complete recovery
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy