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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 |
We 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. We design 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. We choose 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 |
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 |
Estimated Enrollment: | 46 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | March 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
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:
Contact: Chung-Ming Chu, MD | 852 3513 4822 | chucm@ha.org.hk |
Contact: Alsa W Lin, RN | 852 3513 4827 | united13@netvigator.com |
Hong Kong, Kowloon | |
United Christian Hospital | Recruiting |
Kwun Tong, Kowloon, Hong Kong, Kln | |
Contact: Chung-Ming Chu, MD 852 3513 4822 chucm@ha.org.hk | |
Contact: Alsa W Lin, RN 852 3513 4827 united13@netvigator.com | |
Principal Investigator: Chung-Ming Chu, MD | |
Sub-Investigator: Veronica L Chan, MBChB | |
Sub-Investigator: Alice P Cheung, MBChB | |
Sub-Investigator: Wah-Shing Leung, MBChB | |
Sub-Investigator: Judy Y Lam, MBBS | |
Sub-Investigator: Alsa W Lin, RN | |
Sub-Investigator: Kit-Ching Tse, RN | |
Sub-Investigator: Joyce T Liong, MBChB |
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 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00429156 |
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 |
Signs and Symptoms Lung Diseases, Obstructive Respiratory Insufficiency Respiratory Tract Diseases Hypercapnia |
Lung Diseases Respiration Disorders Hypoventilation Signs and Symptoms, Respiratory Pulmonary Disease, Chronic Obstructive |