Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation

This study is currently recruiting participants.
Verified July 2013 by University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Kasper Linde Ankjaergaard, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01513655
First received: January 16, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

Chronic Obstructive Pulmonary Disease, COPD, is characterized by chronic impaired function and capacity of the lungs and airways. COPD and graded from mild to very severe COPD. Colds, inhalation of dust and pollen as well stay in the cold can cause a worsening, a so-called exacerbation in which the airways become inflamed, constricted and filled with secretions. The patient's ability to maintain adequate respiration is affected dramatically and hospitalization is required. The condition treated medically, but in severe cases, it is so critical to patient needs acute respiratory support or NIV (non invasive ventilation).

NIV is a very gentle mask respirator principle, whereby the patient's own breathing supported and does not require anesthesia. A mesh connects the mouth and nose so that the changing air pressure helps the air through the narrowed airways.

Background Normally NIV therapy is used only during hospitalization. Evidence suggests, however, that home NIV treatment of patients who have previously been admitted with a NIV-requiring exacerbation of COPD, may prevent the majority of exacerbations and admissions for this. Furthermore seem home NIV to reduce mortality among COPD patients. This technique increases both safety and quality of life for a group of very vulnerable patients. The effect is not documented. In this project the investigators want to investigate this effect.

The project in practice In practice, the investigators ask all patients admitted with an exacerbation NIV-consuming in the Capital Region, if they want to participate. If the patient wants this, pull the left as to whether he / she will receive usual care (which is internationally approved gold standard) or usual care + NIV. It is here supposed, the patient must sleep with NIV mask on every night.

Both groups attached to the same follow-up in outpatient clinic and a telephone hotline and receive exactly the same care and attention - except for the NIV. Thereby all the differences in the two groups such as the quality of life, functioning, hospitalization frequency, medication use, and especially mortality are certain to be due to the NIV treatment.

The above mentioned are the end points of this study


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Acute Exacerbation of Chronic Obstructive Airways Disease
Chronic Hypercapnic Respiratory Failure
Device: Nightly NIV for at least 6 hours
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Measured by Kaplan Meier plot and logrank as an Intention-to-treat analysis. Secondarily, mortality will be analyzed as Per-protocol as well


Secondary Outcome Measures:
  • Hospitalization frequency [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Measured by Kaplan Meier plot, logrank and absolute data. Both ITT and PP

  • Health related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    measured by the CAT and SRI questionnaires

  • medication status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    use of medication during one year's follow-up

  • Dyspnea [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The MRC dyspnea scale

  • Number of contacts with ER, GP because of COPD [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of days admitted [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NIV group

NIV group is given golden standard COPD care as described in GOLD-guidelines + NIV every night.

Outpatient visits are given every three months

Device: Nightly NIV for at least 6 hours
NIV given on Philips BiPAP Synchrony apparatus. Adjusted by local dept. of pulmonary medicine.
Other Names:
  • BiPAP A30 AVAPS - Philips Respironics
  • SmartCard reader 1003543
No Intervention: Control Group

Control Group is given golden standard COPD care as described in GOLD-guidelines.

Outpatient visits are given every three months


  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient admitted with a NIV-requiring exacerbation of COPD
  • COPD with a FEV1/FVC <0.7 after bronchodilatation.
  • ≥ 1 acute hypercapnic respiratory failure (AHRF *).
  • Optimal medical treatment of COPD, ie. inhaled steroids, long-acting β2-agonist Tiotropium, according to GOLD guidelines.
  • Address in Capital Region
  • Patients are able to give verbal consent and sign a written consent form and understand Danish-

Exclusion Criteria:

  • Severely depressed level of consciousness / confusion / non-cooperative.
  • Respiratory rate <12/min
  • Severe hypoxia, such as requiring more than 15L O2/min.
  • Large amounts of sputum.
  • Vomiting and high risk for aspiration.
  • Inability to accept NIV.
  • Recent abdominal, facial or upper airway surgery.
  • Malignancy or life expectancy <6 months because of disease other than COPD
  • Known obstructive sleep apnea syndrome (OSA)
  • Metabolic acidotic component - StHCO3- < 20 mM
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513655

Contacts
Contact: Philip Tønnesen, MDSc +45 21279858 phtoe@geh.regionh.dk
Contact: Kasper L Ankjærgaard, MD +45 29922755 ankjaergaard@live.dk

Locations
Denmark
Dept. of Pulmonary Medicine Y, UH Gentofte Recruiting
Hellerup, Denmark, DK-2900
Contact: Philip Tønnesen, MD, dr.med.sci    +45 21279858    phtoe@geh.regionh.dk   
Contact: Kasper Linde Ankjærgaard, MD    +45 29922755    ankjaergaard@live.dk   
Dept. of Internal Medicine O, UH Herlev Not yet recruiting
Herlev, Denmark, DK-2730
Contact: Lars Christian Laursen, MD, dr.med.sci    +45 38 68 38 68    lachla01@heh.regionh.dk   
Dept. of Pulmonary Medicine and Infectional Medicine, UH Hillerød Not yet recruiting
Hillerød, Denmark, DK-3400
Contact: Ide Steffensen, MD, Ph.d    +45 4829 6581    idste@hih.regionh.dk   
Dept. of Pulmonary Medicine and Cardiology, UH Hvidovre Not yet recruiting
Hvidovre, Denmark, DK-2650
Contact: Ejvind Frausing, MD    +45 38 62 22 53    ejvind.frausing@hvh.regionh.dk   
Dept. of Pulmonary Medicine, L, UH Bispebjerg Not yet recruiting
København NV, Denmark, DK-2400
Contact: Birgitte Nybo Jensen, MD, dr.med,sci    +45 35312748    bjen0067@bbh.regionh.dk   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Philips Respironics
Investigators
Study Chair: Philip Tønnesen, MDSc Chair of dept., Dept. of Pulmonary Medicine, UH Gentofte
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kasper Linde Ankjaergaard, MD, MD. ph.d-student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01513655     History of Changes
Other Study ID Numbers: 2011-004866-13
Study First Received: January 16, 2012
Last Updated: July 22, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:
COPD
Home NIV
NIV

Additional relevant MeSH terms:
Hypercapnia
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Hypoventilation
Respiratory Insufficiency
Lung Diseases, Obstructive
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014