| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN96523406 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0185116743 |
| Public title | Use of chlorhexidine gluconate 0.2% oral rinse (CHX) to reduce the incidence of nosocomial lower respirarory tract infections in intubated ICU adult patients |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Respiratory: Lower respiratory tract infection |
| Study hypothesis | Does the use of chlorhexidine gluconate 0.2% mouthwash reduce the incidence of nosocomial lower respiratory tract infection in adult patients who are intubated and receiving mechanical ventilation? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Not provided at time of registration |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/08/2002 |
| Anticipated end date | 31/03/2004 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | We propose to administer 15 ml chlorhexidine gluconate or placebo to the buccal, pharangeal, gingival tongue, roof of mouth and tooth surfaces with a sponge swab twice daily to intubated patients who are predicted to require mechanical ventilation. Broncheoalveolar lavage specimen will be sent for culture every 48 h and the following clinical observations will be recorded daily - white cell count, sputum appearance, temperature and chest X-ray changes. The study ends once the patient is extubated but the observations will be recorded for a further 7 days. |
| Primary outcome measure(s) | Aims and objectives: To find out whether the use of chlorhexidine gluconate 0.2% mouthwash reduces the incidence of nosocomial pneumonia in adult patients who are intubated and receiving mechanical ventilation. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Plymouth Hospitals NHS Trust |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Ms Jacqueline Bailey |
| Contact details | ICU Department
Level 04
Derriford Hospital
Plymouth
United Kingdom
PL6 8DH |
| Contact telephone | +44 01752 777111 |
| Contact fax | +44 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN96523406 |
| Date last extracted from ISRCTN register | 17/04/2008 |
