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Trial registered on ANZCTR


Registration number
ACTRN12613000011785
Ethics application status
Approved
Date submitted
15/11/2012
Date registered
7/01/2013
Date last updated
7/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Models of care for Acute Non-invasive Ventilation- Comparison of three tertiary Centres.
Scientific title
Three Acute non-invasive ventilation services based in metropolitan Melbourne in the hospital ward (The Alfred Hospital), high dependency unit (Royal Melbourne Hospital) and intensive care unit (Boxhill Hospital) deliver equivalent patient outcomes and are equally cost effective.
Secondary ID [1] 281546 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACT3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 287815 0
Comparison of models of care for acute non-invasive ventilation across three tertiary centres. 287839 0
Condition category
Condition code
Respiratory 288163 288163 0 0
Chronic obstructive pulmonary disease
Public Health 288182 288182 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective observational non-inferiority study comparing the acute non-invasive ventilation services (NIV) at The Alfred, Royal Melbourne and Boxhill Hospital. All patients received their usual care. Usual care included all medications required to treat an exacerbation of COPD including controlled oxygen, steriods (either inhaled/ oral or Intra venously), current inhaled respiratory medications and antibiotics if required.
Inclusion criteria- Adult patients admitted with Acute exacerbation of chronic pulmonary disease (AECOPD) by standard criteria (GOLD) complicated by acute respiratory acidosis.
Exclusion criteria- Chronic obstructive pulmonary disease (COPD) patients treated with non-invasive ventilation for weaning post mechanical ventilation.
The study duration was 14 months.
Intervention code [1] 286060 0
Not applicable
Comparator / control treatment
Prospective observational non-inferiority study comparing three acute NIV services of equal weight, treating patients admitted with acute exacerbation of COPD complicated by respiratory acidosis.
Control group
Active

Outcomes
Primary outcome [1] 288366 0
Increase in PH with Non invasive ventilation (NIV) treatment for Acute exacerbation of chroninc obstructive pulmonary disease (AECOPD) complicated by respiratory acidosis (3 centre comparison).
Timepoint [1] 288366 0
14 months of data collection March 2011 to may 2012.
Primary outcome [2] 288367 0
Increase in PaCo2 with Non invasive ventilation (NIV) treatment for Acute exacerbation of chroninc obstructive pulmonary disease (AECOPD) complicated by respiratory acidosis (3 centre comparison).
Timepoint [2] 288367 0
14 months of data collection March 2011 to may 2012.
Secondary outcome [1] 299975 0
Survival rates.
Timepoint [1] 299975 0
14 months of data collection March 2011 to may 2012.
Secondary outcome [2] 299976 0
intubation rates.
Timepoint [2] 299976 0
14 months of data collection March 2011 to may 2012.
Secondary outcome [3] 300330 0
Hospital length of stay.
Timepoint [3] 300330 0
14 months of data collected from March 2011 to May 2012
Secondary outcome [4] 300331 0
Total number of patients treated.
Timepoint [4] 300331 0
14 months of data collection March 2011 to May 2012
Secondary outcome [5] 300332 0
NIV machine settings and adherence.
Timepoint [5] 300332 0
14 months of data collection March 2011 to may 2012
Secondary outcome [6] 300334 0
Nursing time per patient.
Timepoint [6] 300334 0
14 months of data collected from March 2011 to may 2012
Secondary outcome [7] 300335 0
Cost analysis per three centres.
Timepoint [7] 300335 0
14 months of data collected March 2011 to May 2012.

Eligibility
Key inclusion criteria
Adult patients admitted with AECOPD by standard criteria (GOLD) complicated by acute respiratory acidosis (PH <7.35, PaC02>45mmHg) managed with BIPAP.
Includes patients who are trialled on NIV but intolerant of treatment.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
COPD patients treated with BIPAP for weaning post mechanical ventilation.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286325 0
Government body
Name [1] 286325 0
Eastern Health research program grant
Address [1] 286325 0
5 Arnold street Box Hill Vic 3128
PH03 98953333
Country [1] 286325 0
Australia
Primary sponsor type
Government body
Name
Eastern Health research program grant
Address
5 Arnold street Box Hill Vic 3128
Country
Australia
Secondary sponsor category [1] 285114 0
None
Name [1] 285114 0
Address [1] 285114 0
Country [1] 285114 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288398 0
The alfred Hospital
Ethics committee address [1] 288398 0
55 commercial road Melbourne
Victoria 3004
Ethics committee country [1] 288398 0
Australia
Date submitted for ethics approval [1] 288398 0
28/02/2011
Approval date [1] 288398 0
04/03/2011
Ethics approval number [1] 288398 0
89/11

Summary
Brief summary
The aim is to compare three different acute non invasive ventilation services in three tertiary centres in Melbourne. All data has been collected on a password protected microsoft access database. Only a select few have the password. This study is a prospective observational study all patients received their usual care and data is de identified.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34955 0
Dr Alan Young
Address 34955 0
Boxhill Hospital (Eastern Health)
Nelson Road, Box Hill VIC 3128


Country 34955 0
Australia
Phone 34955 0
+61 (03)9895 3333
Fax 34955 0
Email 34955 0
Alan.Young@easternhealth.org.au
Contact person for public queries
Name 18202 0
Ms Kerry Parker
Address 18202 0
55 Commercial road Melbourne.
Victoria Australia 3004.
Country 18202 0
Australia
Phone 18202 0
+61390768090
Fax 18202 0
+61390763746
Email 18202 0
k.parker@alfred.org.au
Contact person for scientific queries
Name 9130 0
Dr Alan Young
Address 9130 0
Boxhill Hospital Melbourne
Nelson Road, Box Hill, VIC 3128

Hospital reception: 9895 3333
Country 9130 0
Australia
Phone 9130 0
+61 30419330065
Fax 9130 0
Email 9130 0
Alan.Young@easternhealth.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary