Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201206000389290 Date of Approval: 04/06/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effectiveness of a vaildated evidence based physiotherapy protocol onselected outcomes
Official scientific title The development, implementation and evaluation of an evidence- based physiotherapy protocol for the management of patients in a surgical intensive care unit
Brief summary describing the background and objectives of the trial It is increasingly being recognized that how intensive care services are delivered may have a greater impact on patient outcome than the individual therapies. Uncertainty regarding the optimal physiotherapy service provision model in a surgical intensive care unit (ICU) exists
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Critical Illness
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/11/2008
Actual trial start date 01/11/2008
Anticipated date of last follow up 28/02/2009
Actual Last follow-up date 31/03/2009
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 197
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2003/055/N Faculty Health Sciences Research Ethics comittee Stellenbosch University
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Non-randomised not applicable Patients are admitted to ICU based on specific criteria and the process is managed by the unit director. The director was not informed of the physiotherapy service which was provided to the unit during specific periods Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual care Intermittent service to unit. Limited on-call service. Over weekends four patients are identified by intensivist in most need of therapy. two three week periods All patients are assessed daily and the physiotherapeutic management based on the therapists¿ clinical decision 96
Experimental Group Protocol Care Dedicated service to unit. On-site availability 12 hours during week and 8 hours/day over weekend. 24 hour on call 7 days a week two three week periods All patients are assessed daily and the clinical decisions of therapists guided by internationally validated evidence based protocol 97
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients admitted to the surgical ICU of a tertiary hospital consecutively during two trial periods, 1 November 2008 to 12 December 2008 and again from 5 January to 15 February 2009 were included. Were younger than 16 years of age; Already in the unit on 1 November 2008 Already 5 January 2009. 16 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/08/2008 Stellenbosch University Research Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
Franci van Zyl Road Tygerberg 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Therapeutic Index Scoring Sysytem 28 Item Daily
Primary Outcome Ventilation proportions Daily
Primary Outcome Functional ability within 48 hours after discharge from the unit
Primary Outcome Functional capacity Within 48 hours after discharge from the unit
Secondary Outcome Time on the ventilator Daily
Secondary Outcome Length of stay Admision to hospital Discharge from hospital Admission to unit Discharge from unit
Secondary Outcome Mortality Death in unit Death in the hospital ward
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Surgical Intensive Care Unit in Tygerberg Hospital Francie van Zyl Tygerberg 7500 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research council of South Africa Franci van Zyl Road Tygerberg 7500 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University Franci van Zyl Road Tygerberg 7500 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof AR Coetzee Franci van Zyl Road Tygerberg 7500 South Africa
Prof QA Louw Franci van Zyl Road Tygerberg 7500 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Susan Hanekom sdh@sun.ac.za 0219389496 Franci van Zyl Road
City Postal code Country Position/Affiliation
Tygerberg 7500 South Africa Senior Lecturer Stellenbosch University
Role Name Email Phone Street address
Public Enquiries Susan Hanekom sdh@sun.ac.za 0219389496 Franci van Zyl Road
City Postal code Country Position/Affiliation
Tygerberg 7500 South Africa Senior Lecturer Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Susan Hanekom sdh@sun.ac.za 0219389696 Franci van Zyl
City Postal code Country Position/Affiliation
Tygerberg 7500 South Africa Senior Lecturer Stellenbosch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information