Assesment of Muscular Unloading in Chronic Obstructive Pulmonary Disease (COPD) Patients With NIV

Study Overview
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Brief Summary
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Evaluation of high intensity NIMV in terms of physiological parameters has been performed in short-term studies in COPD patients. However, the support pressure levels used in exacerbated patients seem contradictory and the muscular unloading levels are uncertain. The objective of study is to determine the discharge level of the inspiratory musculature reached at the same pressure support (PS) values in a group of hospital and domiciliary ventilators. Patients with COPD in at least 6 months of treatment with home NIMV and in stable phase of their disease will be included. Eight commercial ventilators will be used, each patient will use 2 different ventilators. A 5 minute record will be taken at baseline (without NIMV). Subsequently, 5 minutes in NIMV in 3 levels of PS (15/10/20) for each ventilator (15/10/20) and patient with expiratory positive airway pressure (EPAP) of 5 centimeters of water (cmH2O) will be recorded. The results will be compared between the different ventilators and PS values using a general linear model for repeated variables to determine the differences between ventilators and PS levels of respiratory muscular unloading in COPD patients

Official Title
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Influence of Ventilator Model and Pressure Support Level in Muscular Unloading in COPD Patients With Non Invasive Ventilation (NIV)

Conditions
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COPD

Intervention / Treatment
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* Device: Basal record
* Device: PS 10 record
* Device: PS 15 record
* Device: PS 20 record


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with COPD diagnoses based on a spirometry performed the previous year during stability. COPD patients with home NIV treatment of at least 6 months with acceptable compliance and adaptation. Stable patients or just before hospital discharge due to an exacerbation with gasometric stability. Exclusion Criteria: Respiratory acidosis in blood gas analysis, just in case of recent exacerbation Patients with restrictive pathology and /or obesity (IMC>35) Poor quality of EMG signals.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilator 1 vs Ventilator 2<br>2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record Pressure Support 10 (PS 10)record Pressure Support 15 (PS 15) record Pressure Support 20 (PS 20) record | Device: Basal record<br>* Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.<br>Device: PS 10 record<br>* PS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>Device: PS 15 record<br>* PS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>Device: PS 20 record<br>* PS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>|
| Experimental: Ventilator 3 vs Ventilator 4<br>2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed.Interventions: Basal record PS10 record PS15 record PS 20 record | Device: Basal record<br>* Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.<br>Device: PS 10 record<br>* PS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>Device: PS 15 record<br>* PS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>Device: PS 20 record<br>* PS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>|
| Experimental: Ventilator 5 vs Ventilator 6<br>2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record PS10 record PS15 record PS 20 record | Device: Basal record<br>* Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.<br>Device: PS 10 record<br>* PS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>Device: PS 15 record<br>* PS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>Device: PS 20 record<br>* PS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>|
| Experimental: Ventilator 7 vs Ventilator 8<br>2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record PS10 record PS15 record PS 20 record | Device: Basal record<br>* Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.<br>Device: PS 10 record<br>* PS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>Device: PS 15 record<br>* PS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>Device: PS 20 record<br>* PS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory muscular unloading (µv) | Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline EMG (µv) record | Parasternal EMG signals interpretation before and without NIV. Spontaneous breathing record. The outcome measure inspiratory muscular effort of the patient in basal conditions. | 1 day | 
| Pressure support 10 EMG (µv) record. V1 | Parasternal EMG signals interpretation during first phase of NIV, in this case it will be programmed at 10 cmH2O os pressure support (PS) with Ventilator 1 during 5 minutes. | 1 day | 
| Pressure support 15 EMG (µv) record. V1 | Parasternal EMG signals interpretation during the second phase of NIV that will be programmed at 15 cmH2O os pressure support (PS) with Ventilator 1 during 5 minutes | 1 day | 
| Pressure support 20 EMG (µv) record. V1 | Parasternal EMG signals interpretation during the last phase of NIV that will be programmed at 20 cmH2O os pressure support (PS) with Ventilator 1 during 5 minutes | 1 day | 
| Pressure support 10 EMG (µv) record. V2 | Paraesternal EMG signals interpretation during the last phase of NIV that will be programmed at 10 cmH2O os pressure support (PS) with Ventilator 2 during 5 minutes | 1 day | 
| Pressure support 15 EMG (µv) record. V2 | Parasternal EMG signals interpretation during the last phase of NIV that will be programmed at 15 cmH2O os pressure support (PS) with Ventilator 2 during 5 minutes | 1 day | 
| Pressure support 20 EMG (µv) record. V2 | Parasternal EMG signals interpretation during the last phase of NIV that will be programmed at 20 cmH2O os pressure support (PS) with Ventilator 2 during 5 minutes | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monitoring NIV, inspiratory muscular unloading, EMG