ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critically ill patients in ICU

Intensive care patient mobilisation practices

Barriers to mobilising intensive care patients

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

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]

Duration of ICU admission for the duration of the audit

Primary outcome [2]

Frequency of patient mobilisation. This outcome will be assessed by reading patient files on MetaVision software and interpreting clinician notes.

Timepoint [2]

Duration of ICU admission for the duration of the audit

Secondary outcome [1]

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]

Duration of patient admission in ICU for the duration of the audit.

Secondary outcome [2]

Identifying barriers to mobilisation. By reading patient files in the ICU, we, will ascertain why patients aren't being mobilised.

Timepoint [2]

Duration of ICU admission for the duration of the audit

Secondary outcome [3]

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]

Duration of ICU admission for the duration of the audit.

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

17/10/2016

Actual

17/10/2016

Date of last participant enrolment

Anticipated

18/11/2016

Actual

18/11/2016

Date of last data collection

Anticipated

18/11/2016

Actual

18/11/2016

Sample size

Target

200

Accrual to date

Final

202

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment hospital [1]

The Canberra Hospital - Garran

Recruitment postcode(s) [1]

2605 - Garran

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Canberra Hospital

Address [1]

Yamba Dr, Garran ACT 2605

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Canberra Hospital

Address

Yamba Dr, Garran ACT 2605

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The Australian National University

Address [1]

Canberra ACT 0200

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Canberra

Address [2]

University Dr, Bruce ACT 2617

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Capital Territory Health, Human Research Ethics Committee, Research Ethics and Governance Office, Low Risk Sub-Committee

Ethics committee address [1]

-

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/08/2016

Approval date [1]

24/08/2016

Ethics approval number [1]

ETHLR.16.160

Ethics committee name [2]

University of Canberra Research Ethics Committee

Ethics committee address [2]

University Drive, Bruce ACT 2617

Ethics committee country [2]

Date submitted for ethics approval [2]

28/09/2016

Approval date [2]

05/10/2016

Ethics approval number [2]

ETHLR.16.160

Ethics committee name [3]

Australian National University, Human Ethics Committee

Ethics committee address [3]

Canberra, ACT, 0200

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

10/09/2016

Approval date [3]

06/10/2016

Ethics approval number [3]

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

Mr Christopher Brock

Address

Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605

Country

Australia

Phone

+61 2 6244 3655

Fax

[email protected]

Contact person for public queries

Name

Christopher Brock

Address

Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605

Country

Australia

Phone

+61 2 6244 3655

Fax

[email protected]

Contact person for scientific queries

Name

Christopher Brock

Address

Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605

Country

Australia

Phone

+61 2 6244 3655

Fax

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	Defining new barriers to mobilisation in a highly active intensive care unit - have we found the ceiling? An observational study.	2018	https://dx.doi.org/10.1016/j.hrtlng.2018.04.004

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically