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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04054622
Enrollment
10
Registered
2019-08-13
Start date
2019-11-01
Completion date
2021-12-31
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COP, Non-invasive Ventilation, Pulmonary Rehabilitation

Keywords

patient-ventilator asynchrony

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

Interventions

None listed

Sponsors

Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Asynchrony index5 hoursAsynchrony 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

MeasureTime frameDescription
Severe Respiratory Insufficiency (SRI) Questionnaire5 hoursThe SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NIV. It includes 49 items on seven subscales.
COPD assessment test5 hoursThe 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.
Partial pressure of arterial blood carbon dioxide (PaCO2)5 hoursDaytime 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.
6-minute walk test5 hoursThe 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

Countries

China

Contacts

Primary ContactZhenfeng He, MD
zfHe_2019@163.com8602083062882

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026