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

Pulmonary Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054622
• Other study ID #: GIRH-201922
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Guangzhou Medical University
• Contact: Zhenfeng He, MD
• Phone: 8602083062882
• Email: zfHe_2019[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COP
• Non-invasive Ventilation
• Pulmonary Rehabilitation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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