- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04521426
Ventilator-associated Injury (VAI) in Chronic Home Mechanical Ventilation
Ventilator-associated Injury (VAI) in Chronic Home Mechanical Ventilation: a Paradigm Switch in Order to Improve Ventilatory Support
Rationale:
The pathophysiological changes in respiratory muscle morphology and functioning in patients with end-stage pulmonary disease are not very well known. Furthermore, in COPD, long-term high-intensity NIV is applied without knowing the exact consequences on the lungs and respiratory muscles.
Objective: The aims of the study are to get insight in:
A. changes respiratory muscles in end-stage respiratory disease, comparing COPD with restrictive lung disease (RLD) due to pulmonary fibrosis B. the effects of long-term HI-NIV in severe COPD patients on the respiratory muscles and the lungs; by comparing COPD patients that had been treated with long-term NIV to COPD patients that were not treated with long-term NIV.
Study design: In order to investigate this, the investigators will include in a small pilot cohort study patients being lung transplanted. In these patients there is lung tissue available and respiratory muscle biopsies will be performed during lung-transplant surgery.
Study population: Patients that are listed for lung transplantation for an underlying diagnosis of COPD or RLD will be asked to participate. Three groups will be included: patients with a RLD due to pulmonary fibrosis, COPD patients that had been treated with long-term NIV prior to being lung transplanted and COPD patients that were not treated with long-term NIV. Patients will be included definitely once being lung transplanted.
Main study parameters/endpoints: The study is an exploratory pilot study. Both contractile strength and the structure of single diaphragm and intercostal muscle fibres as well as lung injury; i.e. alveolar structure and damage and inflammation in the alveoli, will be investigated.
Study Overview
Status
Intervention / Treatment
Detailed Description
Rationale:
Chronic Obstructive Pulmonary Disease (COPD) is a progressive inflammatory disease characterised by airway and lung parenchyma damage. At end-stage disease patients may develop chronic hypercapnic respiratory failure, a disease characteristic that is however not uniformly seen in other end-stage lung diseases, such as in patients with pulmonary fibrosis. The underlying process for the development of chronic hypercapnic respiratory failure is incompletely understood and the role of respiratory muscle alterations is unclear.
Home noninvasive ventilation with high-intensity ventilatory settings (HI-NIV) has been shown to be effective in these severe COPD patients. However, in patients being mechanically ventilated on the intensive care unit for diverse reasons, high-intensity ventilation, especially high tidal volumes, has been shown to result in ventilator associated lung and diaphragm injury. Whether this occurs in home high-intensity NIV, is however completely unknown.
Objective: The aims of the study are to get insight in:
A. changes respiratory muscles in end-stage respiratory disease, comparing COPD with restrictive lung disease (RLD) due to pulmonary fibrosis B. the effects of long-term HI-NIV in severe COPD patients on the respiratory muscles; i.e. the contractile strength and the structure of single diaphragm and intercostal muscle fibres and the lungs; i.e. alveolar structure and damage and inflammation, by comparing COPD patients that had been treated with long-term NIV to COPD patients that were not treated with long-term NIV.
Study design: In order to investigate this, the investigators will include in a small pilot cohort study patients being lung transplanted. In these patients there is lung tissue available and respiratory muscle biopsies will be performed during lung-transplant surgery.
Study population: Patients that are listed for lung transplantation for an underlying diagnosis of COPD or RLD will be asked to participate. Three groups will be included: patients with a RLD due to pulmonary fibrosis, COPD patients that had been treated with long-term NIV prior to being lung transplanted and COPD patients that were not treated with long-term NIV. Patients will be included definitely once being lung transplanted.
Main study parameters/endpoints: The study is an exploratory pilot study. The study aims to get data on respiratory muscle and lung and airway pathology in order to, if important results are observed, set up a larger prospective trial investigating both clinical outcomes and pathology of the respiratory muscles/lungs. Both contractile strength and the structure of single diaphragm and intercostal muscle fibres as well as lung injury; i.e. alveolar structure and damage and inflammation in the alveoli, will be investigated.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Marieke L Duiverman
- Phone Number: 0031-50-3613200
- Email: m.l.duiverman@umcg.nl
Study Locations
-
-
-
Groningen, Netherlands
- University Medical Center Groningen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- RLD: probable or confirmed diagnosis of interstitial pulmonary fibrosis (IPF) or other fibrotic lung disease of unknown origin.
- COPD: GOLD stage III or IV
- Being listed for lung transplantation
Exclusion Criteria:
- Concomitant neuromuscular or systemic/collagen-vascular disease
- Prior lung surgery (except for lung biopsies) or lung volume reduction treatment
- Being unable to understand the patient information and consent for the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lung Fibrosis
|
No other than standard care.
|
COPD standard therapy
|
No other than standard care.
|
COPD with long-term NIV
|
No other than standard care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory muscle morphology and functioning
Time Frame: during surgery
|
Biopsies of the diaphragm and intercostal muscles will be taken during surgery
|
during surgery
|
Ventilator-associated lung injury serum TNF-alfa
Time Frame: during surgery
|
serum TNF-alfa
|
during surgery
|
Ventilator-associated lung injury serum IL-6
Time Frame: during surgery
|
serum IL-6
|
during surgery
|
Ventilator-associated lung injury serum IL-1beta
Time Frame: during surgery
|
serum IL-1beta
|
during surgery
|
Ventilator-associated lung injury serum IL-8
Time Frame: during surgery
|
serum IL-8
|
during surgery
|
Ventilator-associated lung injury serum MIP-2
Time Frame: during surgery
|
serum MIP-2
|
during surgery
|
Ventilator-associated lung injury serum sRAGE
Time Frame: during surgery
|
serum sRAGE
|
during surgery
|
Ventilator-associated lung injury BAL TNF-alfa
Time Frame: during surgery
|
BAL TNF-alfa
|
during surgery
|
Ventilator-associated lung injury BAL IL-6
Time Frame: during surgery
|
BAL IL-6
|
during surgery
|
Ventilator-associated lung injury BAL IL-1beta
Time Frame: during surgery
|
BAL IL-1beta
|
during surgery
|
Ventilator-associated lung injury BAL IL-8
Time Frame: during surgery
|
BAL IL-8
|
during surgery
|
Ventilator-associated lung injury BAL MIP-2
Time Frame: during surgery
|
BAL MIP-2
|
during surgery
|
Ventilator-associated lung injury BAL sRAGE
Time Frame: during surgery
|
BAL sRAGE
|
during surgery
|
Ventilator-associated lung injury basal membrane
Time Frame: during surgery
|
histopathological changes to the basal membrane
|
during surgery
|
Ventilator-associated lung injury alveolar cells
Time Frame: during surgery
|
histopathological changes to type I alveolar cells
|
during surgery
|
Ventilator-associated lung injury edema
Time Frame: during surgery
|
edema in the alveoli and interstitium
|
during surgery
|
Ventilator-associated lung injury fibrin
Time Frame: during surgery
|
interstitial fibrin
|
during surgery
|
Ventilator-associated lung injury inflammatory cells
Time Frame: during surgery
|
Inflammatory cells influx in the alveoli
|
during surgery
|
Ventilator-associated lung injury gene-expression
Time Frame: during surgery
|
Gene-expression profiling of epithelial cells with regard to inflammatory factors
|
during surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilatory use
Time Frame: during surgery
|
Duration of usage (longitudinally and use per day)
|
during surgery
|
Ventilatory settings
Time Frame: during surgery
|
Settings of the NIV
|
during surgery
|
Demographics_age
Time Frame: during surgery
|
age
|
during surgery
|
Demographics_gender
Time Frame: during surgery
|
gender
|
during surgery
|
Demographics_BMI
Time Frame: during surgery
|
BMI
|
during surgery
|
Lung Function_FEV1
Time Frame: during surgery
|
FEV1
|
during surgery
|
Lung Function_FVC
Time Frame: during surgery
|
FVC
|
during surgery
|
Blood gasses_PaCO2
Time Frame: during surgery
|
PaCO2
|
during surgery
|
Blood gasses_HCO3-
Time Frame: during surgery
|
HCO3-
|
during surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAI-HMV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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