Clinical trial NCT04054622: Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise
Official title: Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COP
Non-invasive Ventilation
Pulmonary Rehabilitation
Keywords: patient-ventilator asynchrony
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Asynchrony index
timeFrame: 5 hours
Secondary outcomes:
measure: Severe Respiratory Insufficiency (SRI) Questionnaire
timeFrame: 5 hours
measure: COPD assessment test
timeFrame: 5 hours
measure: Partial pressure of arterial blood carbon dioxide (PaCO2)
timeFrame: 5 hours
measure: 6-minute walk test
timeFrame: 5 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University.
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Health
name: Rongchang Chen, MD
role: STUDY_DIRECTOR
References: