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Completed

NCT Number: NCT03373175

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Parc Tauli, Sabadell, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Basal record

Device

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

PS 10 record

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

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

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

Primary outcomes

  1. Inspiratory muscular unloading (µv)

    Time frame: 1 day

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

Secondary outcomes

  1. Baseline EMG (µv) record

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Acronym: EMGNIV

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Dec 14, 2017
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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