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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2021-05-03

Brief Summary

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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

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Basal record

Intervention Type DEVICE

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

PS 10 record

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Basal record

Intervention Type DEVICE

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

PS 10 record

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Basal record

Intervention Type DEVICE

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

PS 10 record

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Basal record

Intervention Type DEVICE

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

PS 10 record

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Interventions

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Basal record

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No