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Clinical Trials/NCT04054622
NCT04054622
Unknown
Not Applicable

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

Guangzhou Medical University1 site in 1 country10 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COP
Sponsor
Guangzhou Medical University
Enrollment
10
Locations
1
Primary Endpoint
Asynchrony index
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guangzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Zhenfeng He

Principle investigator

Guangzhou Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Asynchrony index

Time Frame: 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 Outcomes

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

Study Sites (1)

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