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

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

• Registration Number: NCT04054622
• Lead Sponsor: Guangzhou Medical University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-11
• Study First Posted: 2019-08-13
• Study Start: 2019-11-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-20
• Last Update Posted: 2021-02-23
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asynchrony index	5 hours	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

Secondary Outcome Measures

Name	Time	Method
Partial pressure of arterial blood carbon dioxide (PaCO2)	5 hours	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.
COPD assessment test	5 hours	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.
6-minute walk test	5 hours	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
Severe Respiratory Insufficiency (SRI) Questionnaire	5 hours	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University.; 🇨🇳 Guangzhou, Guangdong, China