Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
31/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Screaton

ORCID ID

Contact details

Department of Radiology
Box 219
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 216516
nickscreaton@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544116605

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Duration of hospital stay

Secondary outcome measures

Impact of early CT on diagnosis, diagnostic confidence, therapy, patient satisfaction.

Overall trial start date

20/09/2002

Overall trial end date

29/08/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

75

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

20/09/2002

Recruitment end date

29/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Other

Funder name

Cambridge Consortium - Addenbrookes (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/03/2016: No publications found, verifying study status with principal investigator