Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000236291
Ethics application status
Approved
Date submitted
21/07/2007
Date registered
11/05/2009
Date last updated
16/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised trial comparing controlled oxygen therapy with high-flow oxygen therapy in the treatment of patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in the pre-hospital setting
Scientific title
Randomised trial comparing controlled oxygen therapy with high-flow oxygen therapy in the treatment of patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in the pre-hospital setting
Secondary ID [1] 262847 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 2180 0
Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) 4652 0
Condition category
Condition code
Respiratory 2275 2275 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
controlled oxygen therapy to maintain oxygen saturations between 88-92% using nasal prongs and mask oxygen with nebulization of medication done by handheld air driven compressor for the duration of the ambulance transport once off treatment pre hospitally
Intervention code [1] 1900 0
Treatment: Other
Comparator / control treatment
High Flow oxygen therapy- provide high concentration of oxygen 8-10 L/min by Non re-breather mask and all nebulized medication will be driven by 6-8L oxygen for the duration of the transport by ambulance.
Control group
Active

Outcomes
Primary outcome [1] 5803 0
Mortality, death in hospital post treatment by ambulance offerers for AECOPD, or death during the care of ambulance officers
Timepoint [1] 5803 0
Mortality during hospital stay after transport by ambulance and treated for AECOPD, during this episode only
Secondary outcome [1] 5276 0
ventilation - invasive and non invasive required during treatment by Ambulance officers of during stay in hospital after treated pre-hospitally for AECOPD
Timepoint [1] 5276 0
ventilation required during transport or duing hospital admission after transport by Ambulance officers and treated for AECOPD
Secondary outcome [2] 5277 0
arterial blood gas (ABG) results assess within 30 min of arrival after treatment by ambulance for AECOPD
Timepoint [2] 5277 0
Hospital admission within 30min of arrival
Secondary outcome [3] 241804 0
Length of Hospital Stay
Timepoint [3] 241804 0
after treatment for AECOPD by ambulance officers the length of hospital stay during this admission measured in days

Eligibility
Key inclusion criteria
Confirmed Diagnosis COPD, acute respiratory symptoms, Transport and treatment by Tasmanian Ambulance Staff
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Asthma patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Signed consent forms were received. A list of consenting paramedics was compiled, with city and rural area staff listed separately. Staff were listed in the order in which consent forms were received and then randomly assigned to the treatment groups using the random number generator feature in Microsoft Excel. Staff with odd numbers were assigned to the controlled oxygen therapy treatment group and those with even numbers were assigned to the high flow oxygen therapy treatment group. Paramedics were instructed to follow the protocol for the oxygen therapy treatment group to which they were assigned during shifts where they were the designated treating officer. Randomization by officer no concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Staff were listed in the order in which consent forms were received and then randomly assigned to the treatment groups using the random number generator feature in Microsoft Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2440 0
Other Collaborative groups
Name [1] 2440 0
Australian College for Ambulance Professionals
Country [1] 2440 0
Australia
Funding source category [2] 4833 0
University
Name [2] 4833 0
University of Tasmania (UTAS)
Country [2] 4833 0
Australia
Funding source category [3] 4834 0
Self funded/Unfunded
Name [3] 4834 0
Dr Michael Austin
Country [3] 4834 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Richard Wood-Baker
Address
Menzies
Private bag 23
Hobart Tasmania 7001
Country
Australia
Secondary sponsor category [1] 4374 0
None
Name [1] 4374 0
Address [1] 4374 0
Country [1] 4374 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4290 0
Human Research Ethics Committee of Tasmania
Ethics committee address [1] 4290 0
Ethics committee country [1] 4290 0
Australia
Date submitted for ethics approval [1] 4290 0
Approval date [1] 4290 0
Ethics approval number [1] 4290 0

Summary
Brief summary
Purpose to determine if different oxygen therapies for patients having AECOPD in the pre-hospital setting have different outcomes (ie. Mortality, length of hospital stay, requirement for ventilation, difference ABGs)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27714 0
Address 27714 0
Country 27714 0
Phone 27714 0
Fax 27714 0
Email 27714 0
Contact person for public queries
Name 11089 0
Mr. Michael A Austin
Address 11089 0
Department of Respiratory Medicine
Royal Hobart Hospital
Liverpool Street
Hobart TAS 7000
Country 11089 0
Australia
Phone 11089 0
+61 3 6226 7778
Fax 11089 0
Email 11089 0
maaustin@utas.edu.au
Contact person for scientific queries
Name 2017 0
Dr. Michael A Austin
Address 2017 0
Department of Respiratory Medicine, Menzies Research Institute
Macquarie Street
Royal Hobart Hospital
Hobart TAS 7000
Country 2017 0
Australia
Phone 2017 0
+61 3 6226 7778
Fax 2017 0
Email 2017 0
maaustin@utas.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEffect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: randomised controlled trial2010https://doi.org/10.1136/bmj.c5462
N.B. These documents automatically identified may not have been verified by the study sponsor.