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
Protocol serial number	N0185116743
Sponsor	Department of Health (UK)
Funder	Plymouth Hospitals NHS Trust (UK)

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

Ms Jacqueline Bailey
Scientific

ICU Department
Level 04
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Chlorhexidine gluconate
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

Derriford Hospital

Plymouth
PL6 8DH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan