Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135538
Status:
UNKNOWN
Last Update Posted:
2007-04-05
First Post:
2005-08-25
Brief Title:
The Additional Value of Noninvasive Ventilation Next to Rehabilitation in Hypercapnic COPD Patients
Sponsor:
Groningen Research Institute for Asthma and COPD
Organization:
Groningen Research Institute for Asthma and COPD
Study Overview
Official Title:
Does Chronic Ventilatory Support Improve the Outcomes of Rehabilitation in Hypercapnic COPD Patients
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to investigate whether noninvasive ventilation by nose mask during the night has additional benefits next to pulmonary rehabilitation in patients with severe hypercapnic COPD
Detailed Description:
Several randomised controlled trials in patients with stable Chronic Obstructive Pulmonary Disease COPD have demonstrated that pulmonary rehabilitation PR improves dyspnoea exercise tolerance and health-related quality of life Research in this field has been important in our department for several years The first study in this respect was started in 1986 comparing outpatient rehabilitation with rehabilitation in the community in patients with severe COPD This study showed that rehabilitation supervised by a physical therapist in the community is effective for a long period in contrast to outpatient rehabilitation In 1990 the second study started showing that positive initial benefits of home based rehabilitation on quality of life can be maintained for 18 months if the patients visit the local physical therapist once a month
However less positive effects of rehabilitation have been reported in the more severe patients Because of dyspnoea due to inspiratory muscle fatigue patients may not receive an adequate training stimulus and therefore rehabilitation might be less effective In these more severe patients alternative therapies are needed These non-pharmacological treatments include nutritional supplementation oxygen therapy lung transplantation lung volume reduction surgery and ventilatory support
The last few years a discussion within the 4 home mechanical ventilation centres HMV in the Netherlands has been started about the role of chronic ventilatory support in end-stage COPD Theoretically it might be effective because
1 a resetting of the respiratory centre may reduce daytime PaCO2
2 a better internal milieu pH PaO2 PaCO2 may improve peripheral muscle function
3 resting the respiratory muscles during the night may increase their daytime strength and endurance
4 a reduction in the number of nocturnal arousals may improve the quality of sleep Nevertheless none of these mechanisms has been proven and currently there is no evidence that noninvasive positive pressure ventilation NIPPV should be given to stable patients with COPD While several randomised controlled trials RCTs on NIPPV have been published with different outcomes a recent meta-analysis did not show beneficial effects on blood gasses lung function respiratory muscle function and walking distance
In contrast several uncontrolled studies did show clear benefits from NIPPV on gas-exchange dyspnoea and quality of life Possible reasons for these conflicting outcomes are differences in
1 selection of patients
2 adequacy of ventilatory support
3 length of ventilatory support Interestingly it seems that studies with a positive outcome included mainly patients with hypercapnia suggesting this as an important selection criterion
The hypothesis is that long term NIPPV in hypercapnic patients with COPD may improve the effects of rehabilitation at home regarding health status ADL function dyspnoea and exercise tolerance Secondly we like to elucidate the exact mechanisms why NIPPV might be effective in this group of patients
Comparison patients who receive noninvasive ventilation during the night while following a pulmonary rehabilitation program with patients who only follow a rehabilitation program without receiving the noninvasive ventilation
However less positive effects of rehabilitation have been reported in the more severe patients Because of dyspnoea due to inspiratory muscle fatigue patients may not receive an adequate training stimulus and therefore rehabilitation might be less effective In these more severe patients alternative therapies are needed These non-pharmacological treatments include nutritional supplementation oxygen therapy lung transplantation lung volume reduction surgery and ventilatory support
The last few years a discussion within the 4 home mechanical ventilation centres HMV in the Netherlands has been started about the role of chronic ventilatory support in end-stage COPD Theoretically it might be effective because
1 a resetting of the respiratory centre may reduce daytime PaCO2
2 a better internal milieu pH PaO2 PaCO2 may improve peripheral muscle function
3 resting the respiratory muscles during the night may increase their daytime strength and endurance
4 a reduction in the number of nocturnal arousals may improve the quality of sleep Nevertheless none of these mechanisms has been proven and currently there is no evidence that noninvasive positive pressure ventilation NIPPV should be given to stable patients with COPD While several randomised controlled trials RCTs on NIPPV have been published with different outcomes a recent meta-analysis did not show beneficial effects on blood gasses lung function respiratory muscle function and walking distance
In contrast several uncontrolled studies did show clear benefits from NIPPV on gas-exchange dyspnoea and quality of life Possible reasons for these conflicting outcomes are differences in
1 selection of patients
2 adequacy of ventilatory support
3 length of ventilatory support Interestingly it seems that studies with a positive outcome included mainly patients with hypercapnia suggesting this as an important selection criterion
The hypothesis is that long term NIPPV in hypercapnic patients with COPD may improve the effects of rehabilitation at home regarding health status ADL function dyspnoea and exercise tolerance Secondly we like to elucidate the exact mechanisms why NIPPV might be effective in this group of patients
Comparison patients who receive noninvasive ventilation during the night while following a pulmonary rehabilitation program with patients who only follow a rehabilitation program without receiving the noninvasive ventilation
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