Panchabhai 2009.

Methods	Study design: open‐label RCT Location: Mumbai, India Number of centres: 1 Study period: 8 months ‐ dates not stated Funding source: Not stated
Participants	Setting: ICU (mixed medical and surgical), tertiary care hospital Inclusion criteria: all patients admitted to ICU during study period who signed consent Exclusion criteria: pregnant women, those with pneumonia at baseline, those for whom oral care was contraindicated, those with allergy to chlorhexidine Number randomised: 512 Number evaluated: 471 (only 88/83 = 171 on mechanical ventilation) Baseline characteristics (given for 471 who completed the trial only): ‐ Intervention group: age: 35.2 ± 15.9; M/F: 136/88; APACHE II Score: 12 ± (9 ‐ 17) ‐ Control group: age: 36.9 ± 16.2; M/F: 171/76; APACHE II Score: 14 ± (9 ‐ 19)
Interventions	Comparison: Chlorhexidine versus potassium permanganate Experimental group (n = 250): Oral and pharyngeal suction of pooled secretions followed by swabbing of the oral cavity, teeth, palate, buccal spaces, posterior pharyngeal wall, and hypopharynx with normal saline.Then oropharyngeal cleansing, following the same procedure, twice daily with 0.2% chlorhexidine solution Control group (n = 262): Oral and pharyngeal suction of pooled secretions followed by swabbing of the oral cavity, teeth, palate, buccal spaces, posterior pharyngeal wall, and hypopharynx with normal saline.Then oropharyngeal cleansing twice daily, following the same procedure, with 0.01% potassium permanganate solution Non‐intubated participants, rinsed with water, then rinsed and gargled with 10 ml of study solution. No eating/drinking for 1 hour postintervention
Outcomes	1. Incidence of nosocomial pneumonia 2. Day of development of pneumonia 3. Mortality (hospital) 4. Duration of ICU stay
Notes	Sample size calculation: "This study had a statistical power of 75% to detect a 50% reduction in the incidence of nosocomial pneumonia in the study group with 95% level of confidence. Assuming the incidence of pneumonia in the control group was 16%, 506 subjects were required" Email sent to author 14 November 2012
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"..randomly assigned to treatment .... by concealed simple random sampling" No details of sequence generation provided
Allocation concealment (selection bias)	Unclear risk	"..concealed simple randomisation" Unclear whether allocation was concealed from researchers
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label RCT
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Open‐label RCT but "two independent, blinded reviewers made the diagnosis of nosocomial pneumonia"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	26/250 (10%) and 15/262 (5.7%) were excluded from the analysis in the chlorhexidine and control groups respectively. Reasons given were ICU stay < 48 hours, 14/250 versus 6/262, and protocol violation 12/250 and 9/262 respectively
Selective reporting (reporting bias)	Low risk	All planned outcomes reported in full
Other bias	Unclear risk	Baseline parameters only reported for those who completed the study