Improving oral care to prevent pneumonia in ventilated patients

The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia: a Randomized Controlled Trial.

This study is testing if better oral care, like using mouthwash and brushing teeth, can help prevent pneumonia in patients on ventilators in the ICU.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Health Sciences Lahore (other)
• Locations: 2 sites (Lahore, Punjab and 1 other locations)
• Trial ID: NCT06039995 on ClinicalTrials.gov

What this trial studies

This clinical trial is a Randomized Controlled Trial (RCT) conducted at Services Hospital in Lahore, focusing on patients in the ICU who are on mechanical ventilation. The study aims to evaluate whether adding adjuvant oral care, including Chlorhexidine mouthwash, toothbrushing, and oral gel, can reduce the incidence and mortality rates of Ventilator-Associated Pneumonia (VAP) and shorten ICU stays compared to traditional oral care practices. A minimum of 100 eligible subjects will be randomly assigned to either the intervention or control group, with outcomes measured using the Modified Clinical Pulmonary Infection Score (MCPIS). The statistical analysis will be performed using SPSS v22 to assess the effectiveness of the intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are ICU patients aged 18-65 who are on mechanical ventilation and have a MCPIS score between 0 to 5 upon ICU admission.

Not a fit: Patients who may not benefit include those with a history of respiratory illness, immunocompromised individuals, or those who have been on mechanical ventilation for more than 48 hours before ICU admission.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of VAP and improve outcomes for patients in intensive care.

How similar studies have performed: Other studies have shown promising results with similar approaches to oral care in preventing VAP, indicating that this method is not entirely novel but still holds potential for significant impact.

Eligibility criteria

Inclusion Criteria:

* ICU patients on intensive mechanical ventilation aged 18-65 years of either sex with oral ETT in situ.
* MCPIS score between 0 to 5 on first day of admission at ICU

Exclusion Criteria:

* More than 48 hours of mechanical ventilation before ICU admission.
* Previous history of respiratory illness.
* Immunocompromised.
* Ongoing sepsis.
* Pregnancy.
* Presence of dentures.

Where this trial is running

Lahore, Punjab and 1 other locations

• University of Health Sciences — Lahore, Punjab, Pakistan (NOT_YET_RECRUITING)
• Services Hospital — Lahore, Pakistan (RECRUITING)

Study contacts

• Principal investigator: Akash Samuel, MS Nursing — University of Health Sciences Lahore
• Study coordinator: Akash Samuel, MS Nursing

Conditions: Pneumonia, Ventilator-Associated