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

COPD Clinical Trial

— EMGNIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373175
• Other study ID #: 2017632
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: May 3, 2021

Study information

• Verified date: August 2021
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 3, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Basal record
Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.
• 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
• 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
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Parc Tauli	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscular unloading (µv)	Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2.	1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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