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

Sponsor
University of Health Sciences Lahore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06039995
Collaborator
(none)
100
1
2
3
33.1

Study Details

Study Description

Brief Summary

The study in question is a Randomized Controlled Trial (RCT) conducted at Services Hospital, Lahore, over a three-month duration. It aims to assess the effects of including adjuvant oral care as part of traditional oral care in reducing the incidence and mortality rates of Ventilator-Associated Pneumonia (VAP) while also shortening the length of ICU stays among patients on mechanical ventilation. This research holds the potential to bring significant improvements to patient care and reduce the burden of VAP in critical care settings.

Study Objectives:

Population Focus: The study focuses on patients admitted to the intensive care unit (ICU) who are receiving mechanical ventilation.

Research Question: The central question this study seeks to answer is: Does the inclusion of adjuvant oral care alongside traditional oral care reduce the incidence and mortality rates of VAP and shorten the length of ICU stay among patients on mechanical ventilation?

Methodology:

Sample Selection: The study aims to include a minimum of 100 subjects who meet the inclusion criteria. These subjects will be selected through convenient sampling.

Randomization: To ensure unbiased allocation, subjects will be randomly assigned to either the control group or the intervention group using computer software.

Interventions: The intervention group will 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. In contrast, the control group will receive traditional oral care involving the use of 0.2% Chlorhexidine mouthwash only.

Outcome Measures: The study will evaluate the incidence of VAP by employing the Modified Clinical Pulmonary Infection Score (MCPIS). Additionally, demographic characteristics such as age, gender, smoking history, duration of ICU stay, and mortality rates will be compared between the two groups.

Statistical Analysis: Data analysis will be conducted using SPSS version 22, employing appropriate statistical methods and tests to draw meaningful conclusions.

Expected Impact:

The findings of this study hold significant potential to reduce VAP rates and improve patient outcomes in ICU settings. The incorporation of toothbrushing and moisturizing gel alongside Chlorhexidine mouthwash may enhance the cost-effectiveness of treatment and benefit healthcare professionals. This approach could potentially lead to shorter ICU stays, ultimately reducing the burden of VAP in critical care settings.

Furthermore, the implementation of comprehensive oral care practices beyond traditional methods has the potential to improve patient care, decrease mortality rates, and alleviate the strain on healthcare resources by potentially reducing the duration of ICU stays. In sum, this research contributes to the broader goal of reducing the incidence of VAP and enhancing overall patient care in intensive care units.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Comprehensive Oral Care
  • Procedure: Traditional Oral Care
  • Device: Mechanical Tooth Brushing using 0.2% Chlorhexidine
  • Device: Moisturizing Gel
  • Device: Oral care using Cotton swab dipped in 0.2% Chlorhexidine
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia: A Randomized Controlled Trial.
Anticipated Study Start Date :
Oct 10, 2023
Anticipated Primary Completion Date :
Dec 10, 2023
Anticipated Study Completion Date :
Jan 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: (Adjuvant Oral Care) Intervention Group

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
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).
Other Names:
  • Adjuvant oral care as a component of traditional oral care
  • Device: Mechanical Tooth Brushing using 0.2% Chlorhexidine
    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.

    Device: Moisturizing Gel
    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.
    Other Names:
  • Veramin
  • Active Comparator: (Traditional Oral Care) Control Group

    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
    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.

    Device: Oral care using Cotton swab dipped in 0.2% Chlorhexidine
    This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Ventilator-Associated Pneumonia (VAP) [The time frame for assessing the incidence of VAP in this study spans the entire three-month duration of the research conducted at Services Hospital, Lahore.]

      This outcome measures the occurrence of Ventilator-Associated Pneumonia (VAP) among patients who are on mechanical ventilation in the intensive care unit (ICU). It serves as a critical indicator of the effectiveness of the intervention, which includes adjuvant oral care, in reducing the risk of VAP.

    Secondary Outcome Measures

    1. 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.]

      The duration of ICU stay will be recorded for each patient. This data will help evaluate whether the intervention affects the length of ICU stay and potentially reduces healthcare resource utilization

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

      Mortality rates in both the control and intervention groups will be compared to assess if the adjuvant oral care intervention has an impact on patient survival during their ICU stay.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Health Sciences Lahore Punjab Pakistan 54000

    Sponsors and Collaborators

    • University of Health Sciences Lahore

    Investigators

    • Principal Investigator: Akash Samuel, MS Nursing, University of Health Sciences Lahore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Akash Samuel, Principal Investigator, University of Health Sciences Lahore
    ClinicalTrials.gov Identifier:
    NCT06039995
    Other Study ID Numbers:
    • VAP RCT 23
    First Posted:
    Sep 15, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2023