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Sponsors and Collaborators: |
United Christian Hospital Respironics Hong Kong Lung Foundation |
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Information provided by: | United Christian Hospital |
ClinicalTrials.gov Identifier: | NCT00429156 |
The investigators hypothesize that continuation of non-invasive ventilation (NIV) at home after an episode of acute hypercapnic respiratory failure (AHRF) treated by NIV in COPD patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation. The investigators designed this study in a way that recruited COPD patients would be started on home NIV or sham treatment after an episode of AHRF requiring acute NIV. The patients are acclimatised to NIV application after a few days of acute use. The investigators chose occurrence of life-threatening event (recurrent AHRF and death) as the primary endpoint.
Condition | Intervention | Phase |
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Hypercapnic Respiratory Failure Chronic Obstructive Pulmonary Disease |
Device: Home non-invasive ventilation Device: Home non-invasive ventilation (sham) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised Controlled Trial of Continuation of Home Non-Invasive Ventilation vs Sham Ventilation in Survivors of Acute Hypercapnic Respiratory Failure in Chronic Obstructive Pulmonary Disease |
Enrollment: | 46 |
Study Start Date: | January 2007 |
Study Completion Date: | February 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Home non-invasive ventilation
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Device: Home non-invasive ventilation
Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home NIV for 1 year.
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2: Sham Comparator
Home sham non-invasive ventilation with CPAP 5 cm H2O
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Device: Home non-invasive ventilation (sham)
Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home sham NIV (CPAP 5 cm H2O) for 1 year.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hong Kong, Kowloon | |
United Christian Hospital | |
Kwun Tong, Kowloon, Hong Kong, Kln |
Principal Investigator: | Chung-Ming Chu, MD | United Christian Hospital |
Responsible Party: | United Christian Hospital ( Dr C M Chu ) |
Study ID Numbers: | KC/KE 06-0147/FR-1 |
Study First Received: | January 30, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00429156 History of Changes |
Health Authority: | Hong Kong: Ethics Committee |
Non-invasive ventilation Non-invasive positive pressure ventilation Home ventilation Domiciliary ventilation Chronic obstructive pulmonary disease COPD |
Respiratory failure Acute hypercapnic respiratory failure NIV NIPPV Type II respiratory failure |
Hypercapnia Clotrimazole Miconazole Respiration Disorders Tioconazole Hypoventilation Signs and Symptoms Lung Diseases, Obstructive |
Respiratory Insufficiency Respiratory Tract Diseases Lung Diseases Antifungal Agents Signs and Symptoms, Respiratory Salicylhydroxamic acid Pulmonary Disease, Chronic Obstructive |
Trypanocidal Agents Anti-Infective Agents Antiprotozoal Agents Hypercapnia Respiration Disorders Hypoventilation Pharmacologic Actions Signs and Symptoms Antiparasitic Agents |
Lung Diseases, Obstructive Respiratory Insufficiency Respiratory Tract Diseases Therapeutic Uses Lung Diseases Antifungal Agents Signs and Symptoms, Respiratory Salicylhydroxamic acid Pulmonary Disease, Chronic Obstructive |