The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia: A Randomized Controlled Trial.
Phase: NA
Conditions: Pneumonia, Ventilator-Associated
Sponsor: University of Health Sciences Lahore

Official Study Title: The Efficacy of Adjuvant Oral Care in Prevention of 
Ventilator-Associated Pneumonia 
 
 
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ClinicalTrials.gov Identifier 
o NCT06039995 
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Study Design 
o Randomized Controlled Trial 
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Sponsor / Responsible Party 
o University of Health Sciences 
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Study Site 
o Services Hospital, Lahore, Pakistan 
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Principal Investigator 
o Akash Samuel 
University of Health Sciences 
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Document Type 
o Study Protocol 
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Protocol Version 
o Version 1.0 
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Document Date 
o 15 December 2025 
 
 
 
 

Study Protocol 
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Title 
• 
The Efficacy of Adjuvant Oral Care in the Prevention of Ventilator-Associated Pneumonia: A 
Randomized Controlled Trial 
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Background and Rationale 
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Ventilator-associated pneumonia (VAP) is a common and serious complication among 
mechanically ventilated patients in intensive care units (ICUs). Oral colonization by pathogenic 
microorganisms is a recognized contributor to VAP development. Enhanced oral care strategies 
combining mechanical and chemical interventions may reduce microbial load and subsequent 
pulmonary infection. This study evaluates whether adjuvant oral care provides benefit beyond 
traditional oral hygiene practices. 
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Objectives 
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Primary Objective: 
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To compare the incidence of ventilator-associated pneumonia between patients 
receiving adjuvant oral care and those receiving traditional oral care. 
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Secondary Objectives: 
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To compare the duration of ICU stay between the two groups. 
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To compare mortality rates during ICU admission between the two groups. 
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Study Design 
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This was a single-centre, parallel-group, randomized controlled trial conducted over a three-
month period at Services Hospital, Lahore. A total of 100 mechanically ventilated adult patients 
were enrolled and randomly allocated in a 1:1 ratio to either the intervention or control group. 
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Study Population 
• 
Adult patients (18–65 years) admitted to the ICU and receiving mechanical ventilation were 
eligible. All participants were enrolled from Pakistan. Baseline characteristics, including age 
and sex distribution, were comparable between groups. 
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Interventions 
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Intervention Group (Adjuvant Oral Care): 
Patients received comprehensive oral care consisting of: 
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0.2% chlorhexidine mouthwash 
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Mechanical toothbrushing using chlorhexidine 
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Application of moisturizing gel to interior and exterior oral surfaces 
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Control Group (Traditional Oral Care): 
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Patients received routine oral care using cotton swabs dipped in 0.2% chlorhexidine 
mouthwash only. 
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Outcome Measures 
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Primary Outcome: Incidence of ventilator-associated pneumonia during ICU stay. 
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Secondary Outcomes: Duration of ICU stay (days) and mortality during ICU admission. 
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Ethical Considerations: The study was conducted following approval from the relevant human 
subject’s protection review board. No protocol amendments affecting all study sites were reported. 
There were no restrictions on publication rights for investigators.