Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise

Pulmonary rehabilitation programmes including aerobic exercise training have strong evidence of effectiveness in improving exercise capacity, dyspnoea and HRQL in patients with COPD. Therefore, current guidelines recommend pulmonary rehabilitation, including exercise training, in these patients. Non-invasive ventilation(NIV) is increasingly used during exercise training programmes in order to train patients at intensity levels higher than allowed by their clinical and pathophysiological conditions. Patient-ventilator asynchrony (PVA) describes the poor interaction between the patient and the ventilator and is the consequence of the respiratory muscle activity of the patient being opposed to the action of the ventilator.PVA have unfavourable clinical impace on gas exchange, dyspnoea perception, patient comfort and tolerance and reduced adherence to NIV. This study is going to detect whether the PVA will increase when COPD patients exercise with NIV supporingt

Study Overview

• Status: Unknown
• Conditions: Pulmonary Rehabilitation; Non-invasive Ventilation; COP

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD, according to the criteria set by the Global Initiative for Obstructive Lung Disease scientific committee, were asked to participate in the present study. Patients had to meet the following inclusion criteria: 1) Age 40-80, males and females; 2) Stage III and IV COPD; 3) Similar with non-invasive ventilation; 4) Willing to participate in the study; 5) Able to provide informed consent.

Description

Inclusion Criteria:

1. Age 40-80, males and females;
2. Stage III and IV COPD;
3. Similar with non-invasive ventilation;
4. Willing to participate in the study;
5. Able to provide informed consent.

Exclusion Criteria:

1. Presented with an acute exacerbation during previous 3 months;
2. Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
3. Intolerant with NIV

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asynchrony index	Asynchrony index is defined as the number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts: asynchrony Index (expressed in percentage) = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Respiratory Insufficiency (SRI) Questionnaire	The SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NIV. It includes 49 items on seven subscales.	5 hours
COPD assessment test	The COPD Assessment Test is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.	5 hours
Partial pressure of arterial blood carbon dioxide (PaCO2)	Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NIV for at least 1 hour.	5 hours
6-minute walk test	The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases	5 hours

Collaborators and Investigators

• Sponsor: Guangzhou Medical University
• Investigators: Study Director: Rongchang Chen, MD, Guangzhou Institute of Respiratory Health

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 11, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 20, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: patient-ventilator asynchrony
• Other Study ID Numbers: GIRH-201922

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No