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Trial registered on ANZCTR


Registration number
ACTRN12616001420437
Ethics application status
Approved
Date submitted
5/10/2016
Date registered
12/10/2016
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The barriers to mobilising intensive care patients
Scientific title
The barriers to mobilising intensive care patients
Secondary ID [1] 290196 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients in ICU 300352 0
Intensive care patient mobilisation practices 300353 0
Barriers to mobilising intensive care patients 300354 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300221 300221 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will observe and monitor the mobilisation of intensive care patients in the Intensive Care Unit (ICU) for the duration of ICU admission for the four week study limit. Mobilisation of patients in the ICU will be categorised as: not mobilised, passivly mobilised (minimal patient assistance using a sling or other device to hoist a patient out of bed), active transfer mobilisation (patient assists in a transfer from bed to a chair), or active mobilisation (patient marches on the spot for >30sec or is mobilised away from the bed space). No intervention will be conducted
Intervention code [1] 295955 0
Not applicable
Comparator / control treatment
This study will assess the mobilisation practices of patients in the Intensive Care Unit (ICU) at The Canberra Hospital (TCH). During a four-week period over OCT-NOV in 2008, a similar study was conducted in the ICU at TCH. The study found that of the 376 patient days audited, patients were mobilised on 176 patient days with active mobilisation on 76 patient days, active transfer on 40 patient days and passive mobilisation on 60 patient days. Importantly, this study revealed that mechanically ventilated patients could be safely mobilised, and that mechanical ventilation should not be a barrier to mobilisation. Only two adverse events were observed, both hypotensive events requiring cessation of mobilisation, return to bed, fluid loading and a transient increase in vasopressor requirments.
The referred study: LEDITSCHKE, I. A., GREEN, M., IRVINE, J., BISSETT, B. & MITCHELL, I. A. 2012. What are the barriers to mobilizing intensive care patients? Cardiopulm Phys Ther J, 23, 26-9.
Control group
Historical

Outcomes
Primary outcome [1] 299702 0
Type of patient mobilisation (active, active-transfer, passive). This outcome will be assessed by reading patient files on MetaVision software and interpreting clinician notes.
Timepoint [1] 299702 0
Duration of ICU admission for the duration of the audit
Primary outcome [2] 299833 0
Frequency of patient mobilisation. This outcome will be assessed by reading patient files on MetaVision software and interpreting clinician notes.
Timepoint [2] 299833 0
Duration of ICU admission for the duration of the audit
Secondary outcome [1] 327896 0
We will use the Acute Care Index of Function (ACIF), a tool to measure overall patient function to compare the patients in our sample with other published work. The ACIF will assist in our description of our patients and links between barriers to mobilisation and functional level achieved during ICU stay. This outcome will be assessed by reading patient files on MetaVision software and interpreting clinician notes.
Timepoint [1] 327896 0
Duration of patient admission in ICU for the duration of the audit.
Secondary outcome [2] 328246 0
Identifying barriers to mobilisation. By reading patient files in the ICU, we, will ascertain why patients aren't being mobilised.
Timepoint [2] 328246 0
Duration of ICU admission for the duration of the audit
Secondary outcome [3] 328247 0
Assess safety of intensive care patient mobilisation. This will be achieved by reading patient MetaVision files to ascertain any adverse events occurring during mobilisation.
Timepoint [3] 328247 0
Duration of ICU admission for the duration of the audit.
Secondary outcome [4] 328307 0
We will use the ICU Mobility Scale (IMS), a tool to measure overall patient function to compare the patients in our sample with other published work. The IMS will assist in our description of our patients and links between barriers to mobilisation and functional level achieved during ICU stay. This outcome will be assessed by reading patient files on MetaVision software and interpreting clinician notes.
Timepoint [4] 328307 0
Duration of ICU admission for the duration of the audit.

Eligibility
Key inclusion criteria
All patients admitted to the Intensive Care Unit (ICU) at The Canberra Hospital (TCH) for at least 24 hours, for the duration of the study.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not admitted to the ICU at TCH

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study will be largely descriptive. When statistics are applied to analyse the data, all results will be expressed as the mean +/- SEM, or as correlations (least squares linear regression) unless indicated otherwise. GraphPad prism (version 6.01) and R statistical package (version 3.0.2) will be used to generate all graphs and conduct statistical tests. Statistical significance will be set at P < 0.05. Multivariate analysis statistical approach will be conducted in conjunction with the statistical consulting unit at the Australian National University. Approximately 200 patients will be included in the study.

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)
ACT
Recruitment hospital [1] 6707 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 14346 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 294560 0
Hospital
Name [1] 294560 0
The Canberra Hospital
Address [1] 294560 0
Yamba Dr, Garran ACT 2605
Country [1] 294560 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Yamba Dr, Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 293428 0
University
Name [1] 293428 0
The Australian National University
Address [1] 293428 0
Canberra ACT 0200
Country [1] 293428 0
Australia
Secondary sponsor category [2] 293429 0
University
Name [2] 293429 0
University of Canberra
Address [2] 293429 0
University Dr, Bruce ACT 2617
Country [2] 293429 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296020 0
Australian Capital Territory Health, Human Research Ethics Committee, Research Ethics and Governance Office, Low Risk Sub-Committee
Ethics committee address [1] 296020 0
-
Ethics committee country [1] 296020 0
Australia
Date submitted for ethics approval [1] 296020 0
09/08/2016
Approval date [1] 296020 0
24/08/2016
Ethics approval number [1] 296020 0
ETHLR.16.160
Ethics committee name [2] 296079 0
University of Canberra Research Ethics Committee
Ethics committee address [2] 296079 0
University Drive, Bruce ACT 2617
Ethics committee country [2] 296079 0
Date submitted for ethics approval [2] 296079 0
28/09/2016
Approval date [2] 296079 0
05/10/2016
Ethics approval number [2] 296079 0
ETHLR.16.160
Ethics committee name [3] 296095 0
Australian National University, Human Ethics Committee
Ethics committee address [3] 296095 0
Canberra, ACT, 0200
Ethics committee country [3] 296095 0
Australia
Date submitted for ethics approval [3] 296095 0
10/09/2016
Approval date [3] 296095 0
06/10/2016
Ethics approval number [3] 296095 0
2016/579

Summary
Brief summary
Early mobilisation of intensive care patients has been shown to improve functional outcomes, attenuate-ICU acquired weakness, reduced ICU and hospital length of stay and reduce mortality rates at 12 months discharge (Morris et al., 2008, Schweickert et al., 2009). Despite these benefits, there are many barriers (femoral vascular lines, staffing logistics and sedation management), which still prevent adequate mobilisation of ICU patients (Leditschke et al., 2012).
An ICU mobility scale has been generated to qualitatively describe on a continuum the level of mobilisation from nil to independent locomotion of ICU patients. (Hodgson et al., 2014a). A second strongly correlated measure of physical function, the Acute Care Index of Function (ACIF) has also been used to measure ICU patient function, and is advantageous in that it incorporates a neurological assessment and has been shown to predict patient physical function post-ICU discharge (Bissett et al., 2016).
In addition, a multinational consensus statement was also published in 2014 (Hodgson et al., 2014b) outlining the safety criteria for the mobilisation of critically ill patients. The statement described which intensive care patient could be safely mobilised and how they could be mobilised. However, it is still possible that these criteria are somewhat conservative compared to existing practices at Canberra Hospital.
This study will determine the current barriers to mobilisation at Canberra Hospital ICU and ascertain whether these have changed compared to data collected in 2008 (Leditschke et al 2012). This study will also describe the safety of patient mobilisation at Canberra Hospital in the context of the consensus statement (Hodgson et al 2014b) and describe the IMS and ACIF scores of patients mobilised in Canberra Hospital ICU as part of routine practice.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69190 0
Mr Christopher Brock
Address 69190 0
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Country 69190 0
Australia
Phone 69190 0
+61 2 6244 3655
Fax 69190 0
Email 69190 0
u5983414@anu.edu.au
Contact person for public queries
Name 69191 0
Mr Christopher Brock
Address 69191 0
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Country 69191 0
Australia
Phone 69191 0
+61 2 6244 3655
Fax 69191 0
Email 69191 0
u5983414@anu.edu.au
Contact person for scientific queries
Name 69192 0
Mr Christopher Brock
Address 69192 0
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Country 69192 0
Australia
Phone 69192 0
+61 2 6244 3655
Fax 69192 0
Email 69192 0
u5983414@anu.edu.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