NCT03373175

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Basal record	Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.
DEVICE	PS 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
DEVICE	PS 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
DEVICE	PS 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

Timeline

• Start date: 2017-11-30
• Primary completion: 2020-10-30
• Completion: 2021-05-03
• First posted: 2017-12-14
• Last updated: 2021-08-04

Locations

2 sites across 1 country: Spain