The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia.

NCT06039995 | Completed Results

• 1 other identifier: VAP RCT 23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

A Randomized Controlled Trial (RCT) at Services Hospital, Lahore, aims to reduce Ventilator-Associated Pneumonia (VAP) incidence and mortality rates while shortening ICU stays in mechanically ventilated patients by adding adjuvant oral care to traditional practices. Study Objectives: Focus: ICU patients on mechanical ventilation. Question: Does adjuvant oral care reduce VAP rates and ICU stays? Methodology: Sample: Minimum 100 eligible subjects via convenient sampling. Randomization: Computer software for unbiased group allocation. Interventions: Intervention group gets Chlorhexidine mouthwash, toothbrushing, and oral gel; control group gets 0.2% Chlorhexidine mouthwash. Measures: Evaluate VAP using Modified Clinical Pulmonary Infection Score (MCPIS) and compare demographic data. Statistical Analysis: SPSS v22 to analyze data. Expected Impact: Potential to reduce VAP and improve ICU patient outcomes. Cost-effective treatment with adjuvant oral care. Shorter ICU stays, relieving VAP burden. Enhanced patient care, reduced mortality, and resource strain. Aligns with reducing VAP incidence and improving ICU patient care.

Conditions

Pneumonia, Ventilator-Associated

Outcome Measures

Primary Outcomes (1)

• Incidence of Ventilator-Associated Pneumonia (VAP)

  This outcome measures the number of participants who developed ventilator-associated pneumonia (VAP) within the early period following initiation of mechanical ventilation. VAP was assessed using clinical and diagnostic criteria on the fifth day after implementation of the assigned oral care intervention. This outcome was used to evaluate the effectiveness of adjuvant oral care compared with traditional oral care in preventing early-onset VAP.

  Five days after initiation of the assigned oral care intervention.

Secondary Outcomes (2)

• Duration of ICU Stay

  These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.

• Mortality Rates

  These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.

Study Arms (2)

(Adjuvant Oral Care) Intervention Group

EXPERIMENTAL

This group represents the intervention arm of the study. Patients in this arm receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This group is the focus of the study's investigation to determine the effectiveness of adjuvant oral care in reducing the incidence of Ventilator-Associated Pneumonia (VAP) and improving patient outcomes.

Procedure: Comprehensive Oral Care; Device: Mechanical Tooth Brushing using 0.2% Chlorhexidine; Device: Moisturizing Gel

(Traditional Oral Care) Control Group

ACTIVE COMPARATOR

This group represents the control arm of the study. Patients in this arm receive traditional oral care, which involves the use of 0.2% Chlorhexidine mouthwash only.

Procedure: Traditional Oral Care; Device: Oral care using Cotton swab dipped in 0.2% Chlorhexidine

Interventions

Comprehensive Oral Care PROCEDURE

The intervention mentioned in this study involves a combination of oral care strategies for patients in the intervention group. These strategies include: Chlorhexidine Mouthwash: Patients in the intervention group will receive Chlorhexidine mouthwash. Chlorhexidine is known for its effectiveness in maintaining oral hygiene. Toothbrushing: In addition to Chlorhexidine mouthwash, patients in the intervention group will undergo toothbrushing. This involves cleaning the teeth and surrounding oral tissues to ensure thorough oral hygiene. Moisturizing Gel Application: The intervention group will also receive the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This helps in maintaining the moisture content of the oral tissues. These interventions aim to enhance oral care beyond traditional methods, potentially reducing the risk of Ventilator-Associated Pneumonia (VAP) and improving overall patient outcomes in the intensive care unit (ICU).

Also known as: Adjuvant oral care as a component of traditional oral care

(Adjuvant Oral Care) Intervention Group

Traditional Oral Care PROCEDURE

In the control arm, patients receive the intervention known as "Traditional Oral Care." This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene.

(Traditional Oral Care) Control Group

Mechanical Tooth Brushing using 0.2% Chlorhexidine DEVICE

Toothbrushing: In addition to Chlorhexidine mouthwash, patients in the intervention group will undergo toothbrushing. This involves cleaning the teeth and surrounding oral tissues to ensure thorough oral hygiene.

(Adjuvant Oral Care) Intervention Group

Moisturizing Gel DEVICE

Moisturizing Gel Application: The intervention group will also receive the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This helps in maintaining the moisture content of the oral tissues.

Also known as: Veramin

(Adjuvant Oral Care) Intervention Group

Oral care using Cotton swab dipped in 0.2% Chlorhexidine DEVICE

This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene

(Traditional Oral Care) Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (2)

University of Health Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Services Hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Akash Samuel
• Organization: University of Health Sciences

akashsamuel20@gmail.com

+923421532346

Study Officials

• Akash Samuel, MS Nursing

  University of Health Sciences Lahore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: August 1, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)