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

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

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

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: Basal record; Device: PS 10 record; Device: PS 15 record; Device: PS 20 record

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ventilator 1 vs Ventilator 2; 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	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
EXPERIMENTAL: Ventilator 3 vs Ventilator 4; 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	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
EXPERIMENTAL: Ventilator 5 vs Ventilator 6; 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	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
EXPERIMENTAL: Ventilator 7 vs Ventilator 8; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory muscular unloading (µv)	Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Manel Lujan, MD, Corporacion Parc Tauli (Sabadell, Barcelona); Principal Investigator: Javier Sayas, Hospital Universitario 12 De Octubre (Madrid)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2017
• Primary Completion (ACTUAL): October 30, 2020
• Study Completion (ACTUAL): May 3, 2021

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Monitoring NIV, inspiratory muscular unloading, EMG
• Other Study ID Numbers: 2017632

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No