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

• Sponsor: Corporacion Parc Tauli (Other)
• Overall Status: Completed
• CT.gov ID: NCT03373175
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Arms: 4
• Actual Duration (Months): 41.1
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COPD	Device: Basal record; Device: PS 10 record; Device: PS 15 record; Device: PS 20 record	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Influence of Ventilator Model and Pressure Support Level in Muscular Unloading in COPD Patients With Non Invasive Ventilation (NIV)
• Actual Study Start Date: Nov 30, 2017
• Actual Primary Completion Date: Oct 30, 2020
• Actual Study Completion Date: May 3, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Inspiratory muscular unloading (µv) [1 day]

   Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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

4. 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

5. 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

6. 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

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Parc Tauli	Sabadell	Barcelona	Spain	08208
2	Hospital Universitario 12 de Octubre	Madrid		Spain	28041

Sponsors and Collaborators

• Corporacion Parc Tauli

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manel Lujan-Torne, MD, Corporacion Parc Tauli
• ClinicalTrials.gov Identifier: NCT03373175
• Other Study ID Numbers: 2017632
• First Posted: Dec 14, 2017
• Last Update Posted: Aug 4, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Manel Lujan-Torne, MD, Corporacion Parc Tauli: Monitoring NIV, inspiratory muscular unloading, EMG

Study Results

No Results Posted as of Aug 4, 2021