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Non-Invasive Ventilation vs. Sham Ventilation in COPD
This study is currently recruiting participants.
Verified by United Christian Hospital, January 2007
Sponsors and Collaborators: United Christian Hospital
Respironics
Hong Kong Lung Foundation
Information provided by: United Christian Hospital
ClinicalTrials.gov Identifier: NCT00429156
  Purpose

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
Hypercapnic Respiratory Failure
Chronic Obstructive Pulmonary Disease
Device: Home non-invasive ventilation
Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
U.S. FDA Resources
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

Further study details as provided by United Christian Hospital:

Primary Outcome Measures:
  • Time to first life-threatening event (recurrent AHRF and death) within the first year of hospital discharge, after an episode of AHRF treated by acute NIV. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Withdrawal from study, number of readmissions, NIV use, intubation, hospitalised days, blood gases levels in the first year after discharge. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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
1: Active Comparator
Home non-invasive ventilation
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.
2: Sham Comparator
Home sham non-invasive ventilation with CPAP 5 cm H2O
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD patient with AHRF who survives after treatment with NIV and successfully weaned off for at least 48 hours.
  • Patients who have been intubated and mechanically ventilated can be included if they have also been treated with NIV in the same hospital admission
  • Significant obstructive sleep apnoea ruled out by overnight polysomnography done after successful weaning of NIV (Apnoea-hypopnoea index, AHI, < 10/hr
  • Patients willing to give their written informed consent to participate in the study
  • Patients understand that he/she would be randomised into receiving home NIV or sham ventilation
  • Patients who are able to use the home pressure support ventilators after a period of acclimatisation and training before discharge from the hospital

Exclusion Criteria:

  • Patients with non-COPD causes of AHRF (e.g. asthma, bronchiectasis or lobar pneumonia, fibrothorax, acute pulmonary oedema, etc)
  • Patients who have contraindications to NIV and those who refused or failed NIV during an initial 15-minute acclimatization period
  • Active smoker
  • An increase of ≥ 15% in FEV1 after inhaled salbutamol (200μg)
  • Obstructive sleep apnoea (OSA) with apnoea-hypopnoea index (AHI) of ≥ 10/hr
  • Other significant co-morbid conditions that in the investigators' view, would confer an adverse prognosis during the study period, e.g., congestive heart failure, uncontrolled diabetes mellitus, tuberculosis, neoplasms, peripheral vascular disease threatening organ functions
  • Adverse psycho-social circumstances not conducive to home NIV treatment (Appendix 2)
  • On long-term systemic steroid (prednisolone ≥ 7.5 mg per day for ≥ 3 months)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429156

Contacts
Contact: Chung-Ming Chu, MD 852 3513 4822 chucm@ha.org.hk
Contact: Alsa W Lin, RN 852 3513 4827 united13@netvigator.com

Locations
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            
Sponsors and Collaborators
United Christian Hospital
Respironics
Hong Kong Lung Foundation
Investigators
Principal Investigator: Chung-Ming Chu, MD United Christian Hospital
  More Information

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

Keywords provided by United Christian Hospital:
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

Study placed in the following topic categories:
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

ClinicalTrials.gov processed this record on January 16, 2009