COPD
Conditions
Keywords
Monitoring NIV, inspiratory muscular unloading, EMG
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
Interventions
DEVICEBasal record
Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.
DEVICEPS 10 record
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
DEVICEPS 15 record
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
DEVICEPS 20 record
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
Sponsors
Corporacion Parc Tauli
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory muscular unloading (µv) | 1 day | Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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. 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 |
| 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 |
| 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 |
Countries
Spain
Outcome results
None listed