Deventilation Dyspnea in COPD Patients Using NIV

NCT ID: NCT03503123

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2024-03-05

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.

Detailed Description

Rationale: 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.

Objective: 1) To investigate what mechanisms underlie the phenomenon of deventilation dyspnoea in COPD patients. 2) To investigate how the change in electrical impedance, measured with electrical impedance tomography (EIT), is related to the change in inspiratory capacity (IC) before and after sleep.

Study design: This study is an observational cohort study analysing changes occurring due to NIV which could explain the existence of deventilation dyspnoea in certain COPD patients using NIV. Ten patients with and ten patients without deventilation dyspnoea will visit the hospital for an afternoon sleep, during and after which several non-invasive measurements are performed to analyse the changes occurring during and after switching off NIV. In order to investigate the deventilation problem, we will measure:

1. the degree of hyperinflation due to NIV: this will be assessed by measuring the change in end-expiratory lung volume (EELV) with EIT before, during and after NIV, and the change in IC before and after sleeping with NIV.

2. the reduction of respiratory muscle activity due to NIV: this will be assessed by the change in electromyography of the frontal diaphragm before, during and after NIV.

3. the effectiveness of NIV in reducing CO2 level: this will be assessed with transcutaneous CO2 measurements (PtcCO2) before, during and after NIV.

4. the degree of deventilation dyspnoea before and after the afternoon sleep: this will be assessed with a 10-point Borg Scale.

Study population: Twenty severe COPD patients (age>18yr) using chronic NIV will be included in the study: 10 patients with severe symptoms of deventilation dyspnoea (Borg Dyspnoea Scale ≥ 5) and 10 patients without symptoms of deventilation dyspnoea, matched with regard to the degree of static lung hyperinflation and NIV settings.

Main study parameters/endpoints: Knowledge about the changes occurring during NIV in patients with COPD with deventilation dyspnoea. The percent change in EELV, IC, respiratory muscle activity and PtcCO2 will be calculated for both groups and correlated with the degree of deventilation dyspnoea.

Conditions

COPD; Dyspnea; Mechanical Ventilation Complication

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

COPD patients with deventilation dyspnoea

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

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

Intervention Type: 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 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.

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Marieke Duiverman

Post-doc, Pulmonary physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Pulmonary diseases

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

201800263

Identifier Type: -

Identifier Source: org_study_id