Deventilation Dyspnea in COPD Patients Using NIV

NCT03503123 | Completed

• 1 other identifier: 201800263
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF). However, these COPD patients often report severe dyspnoea after switching off from NIV therapy, which leads to discomfort and distress. Currently, it is not known what causes this deventilation dyspnoea and therefore a possible treatment to prevent deventilation dyspnoea is not available. This study investigates possible mechanisms underlying the phenomenon of deventilation dyspnoea in COPD patients by monitoring the effects of NIV on the patient during an afternoon sleep.

Conditions

COPD; Dyspnea; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (4)

• End-expiratory lung volume

  The change in end-expiratory lung volume due to NIV-usage

  Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.

• Inspiratory capacity

  The change in inspiratory capacity due to NIV-usage

  Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.

• Respiratory muscle activity

  The change in respiratory muscle activity due to NIV-usage

  Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.

• Transcutaneous carbon dioxide

  The change in transcutaneous carbon dioxide due to NIV-usage

  Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.

Secondary Outcomes (1)

• Correlation of inspiratory capacity with end-expiratory lung volume

  Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.

Study Arms (2)

COPD patients with deventilation dyspnoea

Ten severe COPD patients (age\>18yr) using chronic NIV with severe symptoms of deventilation dyspnoea (Borg Dyspnoea Scale ≥ 5)

Device: Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.

COPD patients without deventilation dyspnoea

Ten severe COPD patients (age\>18yr) using chronic NIV without symptoms of deventilation dyspnoea, matched with the first cohort/group with regard to the degree of static lung hyperinflation and NIV settings.

Device: Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.

Interventions

Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements. DEVICE

Both groups get the same exposures: with measure physiology in both groups by using non-invasive measurement techniques. The techniques we use are Electrical Impedance Tomography to determine degree of hyperinflation. We use Electromyography to analyse respiratory drive. We measure transcutaneous carbon dioxide to assess the effects of non-invasive ventilation. Thereby, we will perform lung function tests.

COPD patients with deventilation dyspnoea; COPD patients without deventilation dyspnoea

Eligibility Criteria

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

Study Population

Patients will be recruited from the University Medical Center Groningen (UMCG). There is a large population of COPD patients using NIV known at the Home Mechanical Ventilation (HMV) Centre (around 120 patients). The pulmonologists know already at least 10 patients who suffer extremely from deventilation dyspnoea, which could possibly participate in the study.

You may qualify if:

• COPD with a NIV indication using chronic NIV
• Age \> 18 years
• With or without deventilation dyspnea when switching off from NIV (depending on group/cohort)
• Written informed consent is obtained

You may not qualify if:

• COPD exacerbation within 2 weeks preceding the study
• Modification of ventilation within 2 weeks preceding the study
• Having a poor compliance with NIV (usage of \<4 h/day)
• Having other disorders leading to respiratory failure (such as morbid obesity, kyphoscoliosis, neuromuscular diseases, tuberculosis)
• Not being able to sleep 1.5 hour in the afternoon
• Having spinal injury, BMI\>50, damaged or inflamed skin around the thorax or a cardiac pacemaker or other implanted devices

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

Department of Pulmonary diseases

Groningen, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Electromyography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doc, Pulmonary physician

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 19, 2018
• Study Start: August 15, 2019
• Primary Completion: December 15, 2023
• Study Completion: March 5, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)