Use of chlorhexidine gluconate 0.2% oral rinse (CHX) to reduce the incidence of nosocomial lower respiratory tract infections in intubated ICU adult patients
| ISRCTN | ISRCTN96523406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96523406 |
| Secondary identifying numbers | N0185116743 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 11/12/2014
- 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
Ms Jacqueline Bailey
Scientific
Scientific
ICU Department
Level 04
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | Use of chlorhexidine gluconate 0.2% oral rinse (CHX) to reduce the incidence of nosocomial lower respiratory tract infections in intubated ICU adult patients |
| Study objectives | 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? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Lower respiratory tract infection |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Chlorhexidine gluconate |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2002 |
| Completion date | 31/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 31/03/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Plymouth Hospitals NHS Trust (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 |
