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Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

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ClinicalTrials.gov Identifier: NCT01592656
Recruitment Status : Terminated (Lack of budget)
First Posted : May 7, 2012
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

Tracking Information
First Submitted Date  ICMJE May 3, 2012
First Posted Date  ICMJE May 7, 2012
Last Update Posted Date January 16, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2012)
Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional respiratory imaging (FRI) and arterial blood gas (ABG). [ Time Frame: At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV) ]
The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FRI and ABG values in hypercapnic COPD patients treated with long-term NIV.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2012)
Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional imaging (FI) and arterial blood gas (ABG). [ Time Frame: At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV) ]
The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FI and ABG values in hypercapnic COPD patients treated with long-term NIV.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2012)
  • Health related quality of life [ Time Frame: At baseline, after 1 month and after 6 months ]
    Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire
  • Lung function tests [ Time Frame: At baseline, after 1 month and after 6 months ]
    Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
  • Hospital admissions [ Time Frame: After 1 month and after 6 months ]
    Length and frequency of admission, severity of exacerbations, ICU admissions
  • Exercise tolerance [ Time Frame: At baseline, after 1 month and after 6 months ]
    6 minutes walking test and oximetry measurement
  • Local airway volume and resistance [ Time Frame: At baseline, after 1 month and after 6 months ]
    CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics.
  • Prediction of breathing pattern [ Time Frame: At baseline ]
    The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2012)
  • Health related quality of life [ Time Frame: At baseline, after 1 month, after 6 months and after 12 months ]
    Saint George's Respiratory Questionnaire (SGRQ), VAS dyspnea, questionnaire UZA BiPAP, Severe Respiratory Insufficiency (SRI) Questionnaire
  • Lung function tests [ Time Frame: At baseline, after 1 month, after 6 months and after 12 months ]
    Spirometry, reversibility, plethysmography, diffusion, MIP, MEP
  • Hospital admissions [ Time Frame: After 1 month, after 6 months and after 12 months ]
    Length and frequency of admission, severity of exacerbations, ICU admissions
  • Exercise tolerance [ Time Frame: At baseline, after 1 month, after 6 months and after 12 months ]
    6 minutes walking test and oximetry measurement
  • Local airway volume and resistance [ Time Frame: At baseline, after 1 month and after 6 months ]
    CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics.
  • Prediction of breathing pattern [ Time Frame: At baseline ]
    The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJE Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.
Brief Summary In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan will be used for FRI.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Radiation: Functional Respiratory Imaging
    CT-scan of thorax. At baseline, after 1 month and after 6 months.
  • Other: Lung compliance measurement
    At baseline
  • Device: Non-invasive ventilation (Respironics)
    Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 > 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion.
    Other Name: Trilogy device (Respironics)
Study Arms  ICMJE
  • Active Comparator: Non-invasive ventilation (NIV)
    30 patients will receive NIV during 6 months = group 1
    Interventions:
    • Radiation: Functional Respiratory Imaging
    • Other: Lung compliance measurement
    • Device: Non-invasive ventilation (Respironics)
  • Placebo Comparator: Control group
    10 patients will act as control group, they will not be treated with NIV = group 2
    Interventions:
    • Radiation: Functional Respiratory Imaging
    • Other: Lung compliance measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: October 23, 2012)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2012)
20
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: ≥ 40 years old
  • Men and women
  • Written informed consent obtained
  • COPD patients GOLD II, III and IV
  • Persisting hypercapnia (pCO2 > 45 mmHg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the GOLD guidelines
  • Stopped smoking
  • Total lung capacity (TLC) > 85%

Exclusion Criteria:

  • Treatment with home NIV or Continuous Positive Airway Pressure (CPAP)
  • Asthma
  • Restrictive lung disease
  • Symptomatic or uncontrolled heart failure
  • Current malignancy
  • Suspected bad compliance for NIV treatment
  • Pregnant women
  • Not be able to speak the language of the participating center
  • Received an investigational product within 4 weeks prior to inclusion in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01592656
Other Study ID Numbers  ICMJE FLUI-2010-68
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FLUIDDA nv
Study Sponsor  ICMJE FLUIDDA nv
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
Principal Investigator: Peter Wijkstra, MD, PhD University Medical Center Groningen
PRS Account FLUIDDA nv
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP