The diagnostic and therapeutic impact of early computer tomography (CT) in patients with pleuritic chest pain

ISRCTN	ISRCTN31825664
DOI	https://doi.org/10.1186/ISRCTN31825664
Secondary identifying numbers	N0544116605

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 13/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nicholas Screaton
Scientific

Department of Radiology
Box 219
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 216516
Email	nickscreaton@hotmail.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The diagnostic and therapeutic impact of early computer tomography (CT) in patients with pleuritic chest pain: a randomised study
Study objectives	We hypothesise that early contrast-enhanced spiral CT will expedite diagnosis and initiation of appropriate treatment and therefore reduce hospital stay. Primary objective: to assess the impact of early CT on duration of hospital stay. Supplementary objectives: to assess the impact of early CT on diagnosis, diagnostic confidence, therapy, patient satisfaction.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory: Pleuritic chest pain
Intervention	All patients admitted between midnight on Sunday and midday on Friday under the care of the on-call general medical teams or medical admissions unit (MAU) with acute onset of pleuritic chest pain will be considered for inclusion. Consenting patients fulfilling the inclusion criteria will be randomised to either routine practice or early CT. Patients in whom urgent CT is considered necessary as part of routine practice, those under age 18 or with a contraindication to contrast medium administration will be excluded. If deemed clinically necessary patients randomised to the routine practice arm may subsequently be referred for CT. The admitting medical Specialist Registrar will complete an admission questionnaire recording the working diagnosis, diagnostic confidence and the proposed treatment prior to investigation. Patients randomised to early CT will undergo a spiral CT pulmonary angiogram within 24 h of admission, performed between 9 am and 5 pm Monday to Friday. The chest will be imaged during intravenous non-ionic contrast medium administration (130 ml [iopamidol 300]). The supervising radiologist will record a provisional report in the patient¿s hospital notes, and dictate a formal report. A follow-up questionnaire will be distributed to the admitting clinician for completion 24 h after admission in order to determine the working diagnosis and proposed management at that stage. Patients will be asked to complete a patient satisfaction questionnaire 48 h after admission. Three months following discharge, patient's hospital records will be reviewed in order to determine the final diagnosis, number and timings of inpatient investigations and any complications.
Intervention type	Other
Primary outcome measure	Duration of hospital stay
Secondary outcome measures	Impact of early CT on diagnosis, diagnostic confidence, therapy, patient satisfaction.
Overall study start date	20/09/2002
Completion date	29/08/2003

Eligibility

Participant type(s)	Patient
Age group	Other
Lower age limit	18 Years
Upper age limit	95 Years
Sex	Both
Target number of participants	75
Key inclusion criteria	1. 75 subjects aged 18-95 years 2. Admitted between midnight on Sunday and midday on Friday under the care of the on-call general medical teams or medical admissions unit (MAU) with acute onset of pleuritic chest pain 3. Informed consent
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	20/09/2002
Date of final enrolment	29/08/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrooke's NHS Trust

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Other

Cambridge Consortium - Addenbrookes (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/04/2018: No publications found, verifying study status with principal investigator.
31/03/2016: No publications found, verifying study status with principal investigator.