Respiratory EMG for NIV Titration in Stable COPD Patients

NCT02629055 | Terminated DMC

• 1 other identifier: 2015/383
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate whether additional titration on surface electromyography (EMG) of the diaphragm and intercostal muscles improves the outcome of chronic non-invasive ventilation in patients with COPD and stable chronic hypercapnic respiratory failure in terms of better gas exchange after six weeks, lung function, patient comfort and compliance, and less patient ventilator asynchrony. Therefore, the investigators set up a randomized, two-armed crossover trial comparing regular titration with additional respiratory EMG titration of NIV.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Non-invasive ventilation; Respiratory electromyography

Outcome Measures

Primary Outcomes (1)

• Nocturnal gas exchange (PCO2 (kPa))

  PCO2 will be assessed with transcutaneous measurements (TOSCA, Linde Medical Sensors AG, Basel)

  6 weeks

Secondary Outcomes (5)

• Patient comfort measured with a Visual Analogue Scale

  6 weeks

• Health related quality of life measured with the Severe Respiratory Insufficiency (SRI) questionaire

  6 weeks

• Lung volumes

  6 weeks

• Respiratory muscle strength

  6 weeks

• Patient-Ventilator Asynchrony (PVA)

  6 weeks

Study Arms (2)

Respiratory EMG

EXPERIMENTAL

Additional EMG measurements whilst on NIV will be used to guide the titration of NIV.

Other: Respiratory EMG

Care as usual

NO INTERVENTION

NIV will be initiated according to standard care protocol.

Interventions

Respiratory EMG OTHER

Titration of non-invasive ventilation on surface respiratory muscle activity

Respiratory EMG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Obstructive Pulmonary Disease (COPD) Global initiative of chronic Obstructive Lung Diseases (GOLD) stage III or IV (FEV1 \<50 % predicted, FEV1/forced expiratory volume (FVC) \< 70% predicted)
• Indication for the initiation of chronic NIV: PaCO2 \>6.0 kilopascal (kPa) at rest during daytime.
• Stable COPD (pH \>7.35, no exacerbation in the past two weeks)
• Age \>18 years

You may not qualify if:

• Respiratory insufficiency of any other cause.
• Already initiated on chronic NIV.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Marieke L Duiverman, Dr

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 11, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

NL (1)