Clinical trial NCT03373175: Assesment of Muscular Unloading in Chronic Obstructive Pulmonary Disease (COPD) Patients With NIV
Official title: Influence of Ventilator Model and Pressure Support Level in Muscular Unloading in COPD Patients With Non Invasive Ventilation (NIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Monitoring NIV, inspiratory muscular unloading, EMG
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Inspiratory muscular unloading (µv)
timeFrame: 1 day
Secondary outcomes:
measure: Baseline EMG (µv) record
timeFrame: 1 day
measure: Pressure support 10 EMG (µv) record. V1
timeFrame: 1 day
measure: Pressure support 15 EMG (µv) record. V1
timeFrame: 1 day
measure: Pressure support 20 EMG (µv) record. V1
timeFrame: 1 day
measure: Pressure support 10 EMG (µv) record. V2
timeFrame: 1 day
measure: Pressure support 15 EMG (µv) record. V2
timeFrame: 1 day
measure: Pressure support 20 EMG (µv) record. V2
timeFrame: 1 day
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Corporacion Parc Tauli (Sabadell, Barcelona)
name: Manel Lujan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre (Madrid)
name: Javier Sayas
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lalmolda C, Florez P, Corral M, Hernandez Voth A, Grimau C, Sayas J, Lujan M. Does the Efficacy of High Intensity Ventilation in Stable COPD Depend on the Ventilator Model? A Bench-to-Bedside Study. Int J Chron Obstruct Pulmon Dis. 2022 Jan 14;17:155-164. doi: 10.2147/COPD.S327994. eCollection 2022.