Assesment of Muscular Unloading in Chronic Obstructive Pulmonary Disease (COPD) Patients With NIV
- Conditions
- COPD
- Interventions
- Device: Basal recordDevice: PS 10 recordDevice: PS 15 recordDevice: PS 20 record
- Registration Number
- NCT03373175
- Lead Sponsor
- Corporacion Parc Tauli
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ventilator 1 vs Ventilator 2 PS 20 record 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 Ventilator 3 vs Ventilator 4 PS 15 record 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 Ventilator 3 vs Ventilator 4 PS 20 record 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 Ventilator 1 vs Ventilator 2 PS 10 record 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 Ventilator 1 vs Ventilator 2 PS 15 record 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 Ventilator 3 vs Ventilator 4 Basal record 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 Ventilator 3 vs Ventilator 4 PS 10 record 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 Ventilator 5 vs Ventilator 6 PS 20 record 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 Ventilator 7 vs Ventilator 8 PS 20 record 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 Ventilator 5 vs Ventilator 6 PS 15 record 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 Ventilator 7 vs Ventilator 8 Basal record 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 Ventilator 1 vs Ventilator 2 Basal record 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 Ventilator 5 vs Ventilator 6 Basal record 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 Ventilator 7 vs Ventilator 8 PS 10 record 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 Ventilator 5 vs Ventilator 6 PS 10 record 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 Ventilator 7 vs Ventilator 8 PS 15 record 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
- Primary Outcome Measures
Name Time Method Inspiratory muscular unloading (µv) 1 day Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2.
- Secondary Outcome Measures
Name Time Method Pressure support 10 EMG (µv) record. V1 1 day 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.
Pressure support 10 EMG (µv) record. V2 1 day 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
Pressure support 20 EMG (µv) record. V2 1 day 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
Baseline EMG (µv) record 1 day Parasternal EMG signals interpretation before and without NIV. Spontaneous breathing record. The outcome measure inspiratory muscular effort of the patient in basal conditions.
Pressure support 15 EMG (µv) record. V1 1 day 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
Pressure support 20 EMG (µv) record. V1 1 day 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
Pressure support 15 EMG (µv) record. V2 1 day 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
Trial Locations
- Locations (2)
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Parc Tauli
🇪🇸Sabadell, Barcelona, Spain