Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Debbie Thackray


Contact details

School of Health Sciences
University of Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 5471

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

An investigation into clinical reasoning within the context of critical care for cardiorespiratory physiotherapists using SimMan® (Laerdal™): a qualitative observational study using a mixed methods approach of video recording, thinking aloud and debrief interviews


Study hypothesis

The study will identify the clinical decision making process used by expert respiratory physiotherapists in the acute setting.

Ethics approval

School of Education Research Ethics Committee (University of Southampton), 21/12/2009

Study design

Qualitative observational study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet


Post-operative respiratory complications


This is an interpretive observational study using mixed methods of simulation: video, think aloud and debrief interviews.

A patient scenario will be designed and operated through the computerised manikin SimMan® (Laerdal™) at the VIP suite, Building 67, School of Health Sciences University of Southampton. The simulated scenario and environment will be set up to be as realistic as possible. A nurse will be present at the patients bedside and will be able to answer any questions about the patient and his care. The patient's notes and charts will all be available. The individual physiotherapist will be invited to assess the simulated patient and to form a problem list and treatment plan. This is anticipated to take as long as it would in clinical practise so approximately 20 - 40 minutes duration.

This will be followed by a debrief interview where the participant can view their assessment and can comment about their performance - approximately 20 - 30 minutes.

The data from the video, the think aloud and the debrief interview will be analysed using content analysis to find if there are any common themes between the participants.

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Create a realistic simulated critical care scenario, using anonymised real patient data. The scenario has been written - pilot study to take place on July 16th, 2010.
2. Observe and record the clinical decision making processes used by expert physiotherapists. First set of data to be collected 26th, 27th, 28th July 2010.
3. Identify the knowledge, skills and behaviour of the decision making process of expert physiotherapists in a simulated critical care environment. This will be interpretive from the three sets of data - video, think aloud and debrief interviews. Measures will be taken to verify the reliability the assessment by the participant in the debrief interview, intra-reliability measures will be taken to ensure that each set of data is categorised in the same way in the content analysis.

Secondary outcome measures

1. Produce a conceptual framework of the clinical decision making used by expert physiotherapists when assessing and treating the critically ill patient. This will be produced when all 10 participants, data has been collated and analysed - September 2012.
2. From the conceptual framework produce an educational strategy for teaching clinical decision making in critical care. At the end of the study - December 2012 - the video clips will be embedded into power point and modified to use the audience response system so as to facilitate clinical reasoning with undergraduate (UG) students.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Band 8, band 7, band 6 cardio respiratory physiotherapists working in critical care, intensive care units (ICU) or high dependency units (HDU)
2. At least 3 years clinical experience
3. At least 6 weeks recent experience in adult cardiorespiratory care
4. All participants must be familiar with working out of hours (twilight, on call, weekend rotas) and be managing independently their own caseload and making their own clinical decisions and willing and able to discuss their clinical decision making
5. Average age between 25 - 45 years, either sex

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Physiotherapy students will be excluded as they are not yet working independently in this field
2. Any qualified physiotherapists who have not practised within the last 6 months in adult cardiorespiratory physiotherapy and have less than 3 years experience

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

School of Health Sciences
SO17 1BJ
United Kingdom

Sponsor information


University of Southampton (UK)

Sponsor details

Research Governance Office
Corporate Services
Highfield Campus
SO17 1BJ
United Kingdom
+44 (0)23 8059 5781

Sponsor type




Funder type

Research organisation

Funder name

Physiotherapy Research Foundation (PRF) (UK) (ref: PRF/09/3)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/03/2017: No publications found in PubMed, verifying study status with principal investigator