Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114426
Status:
TERMINATED
Last Update Posted:
2005-08-17
First Post:
2005-06-14
Brief Title:
Effects of NIMV on the Health Status of Chronic Obstructive Pulmonary Disease COPD Patients
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Effects of Nocturnal Noninvasive Mechanical Ventilation on the Health Status of Patients With COPD
Status:
TERMINATED
Status Verified Date:
2005-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this proposal we will implement a randomized controlled trial to determine whether nocturnal NIMV applied for 3 months 1 improves disease-specific health related quality of life HRQL of COPD patients compared to a control group of patients treated with sham NIMV therapy primary outcome 2 improves exercise tolerance and walking capacity of COPD patients and 3 improves heart rate variability and decreases sympathetic tone in COPD
Detailed Description:
COPD is one of the fastest growing conditions in the world affecting over 16 million people in the US and over 1 million in Canada and costing society over 23 billion per annum in the US Its prevalence has risen by 41 since 1982 and the age-adjusted death rate has increased by 17 between 1966 and 1982 in contrast to the decline in the age-adjusted death rates from all other causes during the same time period By 2020 COPD will become the third leading cause of death currently 4th representing 5 of all deaths worldwide and 5th leading cause of disability currently 12th worldwide Ironically despite the rapidly growing public health burden of COPD it is the most underfunded disease among all major causes of mortality in North America Despite some progress in the management of COPD over the past two decades there is still a paucity of efficacious therapies that can effectively modify the natural course of this disease
There is a growing interest in nocturnal non-invasive mechanical ventilation NIMV therapy for long-term COPD management for several reasons It may restore inspiratory rate which diminishes by 30 during rapid eye movement REM sleep improve gas exchange and rest chronically tired respiratory muscles in COPD Indeed several uncontrolled studies have provided some empirical evidence to support the use of nocturnal NIMV in COPD However there is a paucity of well-designed controlled trials evaluating this novel therapy particularly for COPD patients at a high-risk for morbidity and mortality
In this proposal we will implement a randomized controlled trial to determine whether nocturnal NIMV applied for 3 months 1 improves disease-specific health related quality of life HRQL of COPD patients compared to a control group of patients treated with sham NIMV therapy primary outcome 2 improves exercise tolerance and walking capacity of COPD patients 3 reduces the number of clinical relapses in COPD patients 4 improves heart rate variability and decreases sympathetic tone in COPD and 5 is a cost-effective therapy
We will carefully select COPD patients ready for discharge from an acute care hospital and will be invited to participate in this trial Participants will then undergo a run-in phase of 4 weeks during which their clinical status will be stabilized Patients experiencing a clinical exacerbation during the run-in phase will be excluded from the study After the run-in phase patients will be randomly assigned to one of two groups nocturnal NIMV therapy standard medical therapy or sham standard medical therapy The Chronic Respiratory Questionnaire CRQ and the Health Utilities Index Mark 23 HUI 2 and HUI 3 will be used to measure HRQL of study participants at baseline and then at 2 4 6 8 10 and 12 weeks We will also measure the study participants exacerbation rate during the study period A six-minute walk test will be used to determine the walking capacity of the study participants In addition 2-D echocardiography and 24-hour ambulatory electrocardiographic monitoring will be used to determine the effect of nocturnal NIMV on cardiac performance over a 3 month period Finally we will perform a comprehensive economic analysis to determine the costs as well as the benefits associated with the nocturnal NIMV therapy
We anticipate that this study will show that those treated with nocturnal NIMV therapy will have better HRQL at 3 months compared to those on sham therapy and this will be associated with improved walking capacity and decreased rates of exacerbation We also anticipate that nocturnal NIMV therapy will improve heart rate variability and lower pulmonary arterial pressure during daytime
There is a growing interest in nocturnal non-invasive mechanical ventilation NIMV therapy for long-term COPD management for several reasons It may restore inspiratory rate which diminishes by 30 during rapid eye movement REM sleep improve gas exchange and rest chronically tired respiratory muscles in COPD Indeed several uncontrolled studies have provided some empirical evidence to support the use of nocturnal NIMV in COPD However there is a paucity of well-designed controlled trials evaluating this novel therapy particularly for COPD patients at a high-risk for morbidity and mortality
In this proposal we will implement a randomized controlled trial to determine whether nocturnal NIMV applied for 3 months 1 improves disease-specific health related quality of life HRQL of COPD patients compared to a control group of patients treated with sham NIMV therapy primary outcome 2 improves exercise tolerance and walking capacity of COPD patients 3 reduces the number of clinical relapses in COPD patients 4 improves heart rate variability and decreases sympathetic tone in COPD and 5 is a cost-effective therapy
We will carefully select COPD patients ready for discharge from an acute care hospital and will be invited to participate in this trial Participants will then undergo a run-in phase of 4 weeks during which their clinical status will be stabilized Patients experiencing a clinical exacerbation during the run-in phase will be excluded from the study After the run-in phase patients will be randomly assigned to one of two groups nocturnal NIMV therapy standard medical therapy or sham standard medical therapy The Chronic Respiratory Questionnaire CRQ and the Health Utilities Index Mark 23 HUI 2 and HUI 3 will be used to measure HRQL of study participants at baseline and then at 2 4 6 8 10 and 12 weeks We will also measure the study participants exacerbation rate during the study period A six-minute walk test will be used to determine the walking capacity of the study participants In addition 2-D echocardiography and 24-hour ambulatory electrocardiographic monitoring will be used to determine the effect of nocturnal NIMV on cardiac performance over a 3 month period Finally we will perform a comprehensive economic analysis to determine the costs as well as the benefits associated with the nocturnal NIMV therapy
We anticipate that this study will show that those treated with nocturnal NIMV therapy will have better HRQL at 3 months compared to those on sham therapy and this will be associated with improved walking capacity and decreased rates of exacerbation We also anticipate that nocturnal NIMV therapy will improve heart rate variability and lower pulmonary arterial pressure during daytime
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None