Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001678482
Ethics application status
Approved
Date submitted
1/12/2016
Date registered
6/12/2016
Date last updated
1/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobilisation of intensive care patients receiving blood pressure support medications: an observational study
Scientific title
Mobilisation of vasopressor-dependent intensive care patients: an observational study.
Secondary ID [1] 290664 0
Nil known
Universal Trial Number (UTN)
U1111-1190-5022
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive care patients 301193 0
Vasopressor-dependent Hypotension 301194 0
Condition category
Condition code
Cardiovascular 300944 300944 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 300978 300978 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All vasopressor-dependent patients who experienced mobilisation with physiotherapists in the ICU at Canberra hospital will be described in this retrospective study. The time frame studied will be October 1 - December 31 2016. Mobilisation includes all activities which facilitate out-of-bed movement, including sitting on the edge of the bed, sitting in a chair, standing, marching on the spot and standing with the assistance of equipment (eg tilt table or gait harness).
Intervention code [1] 296543 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300368 0
Safety - incidence of adverse events, as documented in medical record by treating physiotherapist.
Timepoint [1] 300368 0
At time of mobilisation
Secondary outcome [1] 329804 0
Level of mobilisation achieved, as described by the treating physiotherapist using the ICU mobility scale (IMS) in the medical record
Timepoint [1] 329804 0
At time of mobilisation
Secondary outcome [2] 329805 0
Overall functional level achieved, using the Acute Care Index of Function score (ACIF) as recorded by the treating physiotherapist in the medical record.
Timepoint [2] 329805 0
At ICU discharge
Secondary outcome [3] 329865 0
Frequency of mobilisation
Timepoint [3] 329865 0
Throughout ICU admission within the audit period as documented in the medical record
Secondary outcome [4] 329866 0
Vasopressor dosage
Timepoint [4] 329866 0
During each mobilisation episode as documented by nursing staff in the medical record

Eligibility
Key inclusion criteria
All vasopressor-dependent adult patients who experience mobilisation as part of their routine physiotherapy intervention in ICU
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not receiving vasopressor medication at the time of mobilisation
Aged < 18 years

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Descriptive analyses will be used to best describe the sample in terms of demographics, level of vasopressor support and mobilisation / functional level achieved at time of intervention and at ICU discharge, as well as incidence of adverse events.
Correlational analyses will be used to describe any associations between level of vasopressor support and level of mobilisation achieved, and between level of mobilisation achieved and overall functional level at ICU discharge.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2017
Actual
9/01/2017
Date of last participant enrolment
Anticipated
31/01/2017
Actual
31/01/2017
Date of last data collection
Anticipated
31/01/2017
Actual
31/01/2017
Sample size
Target
50
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 7036 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 14768 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 295093 0
University
Name [1] 295093 0
University of Canberra
Country [1] 295093 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Building 12D44
University Drive
Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 293913 0
Hospital
Name [1] 293913 0
The Canberra Hospital
Address [1] 293913 0
Building 15
Department of Physiotherapy
Canberra Hospital
Yamba Drive Garran ACT 2605
Country [1] 293913 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296453 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 296453 0
PO Box 11
Woden ACT 2606
Ethics committee country [1] 296453 0
Australia
Date submitted for ethics approval [1] 296453 0
04/10/2016
Approval date [1] 296453 0
12/10/2016
Ethics approval number [1] 296453 0
ETHLR.16.145

Summary
Brief summary
Early rehabilitation of intensive care (ICU) patients is essential to reduce the residual burden of ICU-acquired weakness. While various guidelines have been published regarding safety criteria for mobilizing ICU patients (eg Hodgson et al 2014), there is little clarity regarding the safety of mobilizing patients receiving drugs which support blood pressure (vasopressors).
At Canberra Hospital ICU, we have a well-established routine practice of mobilizing ICU patients (eg Green et al 2016, Leditschke et al 2012, Green et al 2009), including those receiving vasopressors. Note that ‘mobilisation’ can include standing people in a relatively passive way (eg with tilt table equipment) and / or sitting patients over the edge of the bed etc. Thus we can mobilise even sedated and / or delirious patients if required. There is very little data about the relationship between vasopressor dose and mobility level that is achievable in ICU.
We wish to describe our usual practice in detail, including accurate quantification of frequency of mobilisation and corresponding dosage of vasopressors. This information will be useful not just to inform our own future practice, but also to other ICU clinicians around the world who seek more clarity on safety criteria for mobilizing patients in ICU.
This study is a simple retrospective audit of our usual practice which will allow us to describe our mobilisation practices across a 3 month period. All the information required for this study is already collected routinely in the Metavision computer program in ICU, thus this study will not pose any additional burden to patients or staff. It is intended that the results of this study would be published in a reputable critical care journal, as well as presented at scientific meetings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70882 0
Dr Bernie Bissett
Address 70882 0
Building 12D44
University Drive
University of Canberra
Bruce ACT 2617
Country 70882 0
Australia
Phone 70882 0
+61 2 6201 2566
Fax 70882 0
Email 70882 0
Bernie.Bissett@canberra.edu.au
Contact person for public queries
Name 70883 0
Dr Bernie Bissett
Address 70883 0
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 70883 0
Australia
Phone 70883 0
+61 2 6244 2154
Fax 70883 0
Email 70883 0
Bernie.Bissett@act.gov.au
Contact person for scientific queries
Name 70884 0
Dr Bernie Bissett
Address 70884 0
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 70884 0
Australia
Phone 70884 0
+61 2 6244 2154
Fax 70884 0
Email 70884 0
Bernie.Bissett@act.gov.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
No additional documents have been identified.