Deventilation Dyspnea in COPD Patients Using NIV

COPD Clinical Trial

Official title:

Deventilation Dyspnea in Patients With Chronic Obstructive Pulmonary Disease After Switching Off From Non-invasive Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03503123
• Other study ID #: 201800263
• Status: Recruiting
• Start date: August 15, 2019
• Est. completion date: December 5, 2023

Study information

• Verified date: May 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 5, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Dyspnea
• Mechanical Ventilation Complication

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Department of Pulmonary diseases	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Correlation of inspiratory capacity with end-expiratory lung volume	To validate Electrical Impedance Tomography measurements to determine end-expiratory lung volume, we will compare these outcomes with the golden standard inspiratory capacity.	Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.