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 |
| Protocol serial number | N0544116605 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrookes (UK) |
- 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
Scientific
Department of Radiology
Box 219
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 216516 |
|---|---|
| nickscreaton@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) | Duration of hospital stay |
| Key secondary outcome measure(s) | Impact of early CT on diagnosis, diagnostic confidence, therapy, patient satisfaction. |
| Completion date | 29/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 18 Years |
| Upper age limit | 95 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
