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

Primary Purpose

Pneumonia, Ventilator-Associated

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Comprehensive Oral Care
Traditional Oral Care
Mechanical Tooth Brushing using 0.2% Chlorhexidine
Moisturizing Gel
Oral care using Cotton swab dipped in 0.2% Chlorhexidine
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia, Ventilator-Associated

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

(Adjuvant Oral Care) Intervention Group

(Traditional Oral Care) Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Ventilator-Associated Pneumonia (VAP)
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

Duration of ICU Stay
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
Mortality Rates
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.

Full Information

First Posted
September 10, 2023
Last Updated
September 21, 2023
Sponsor
University of Health Sciences Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT06039995
Brief Title
The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia.
Official Title
The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Health Sciences Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-Associated

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
(Adjuvant Oral Care) Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
(Traditional Oral Care) Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Comprehensive Oral Care
Other Intervention Name(s)
Adjuvant oral care as a component of traditional oral care
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Traditional Oral Care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Mechanical Tooth Brushing using 0.2% Chlorhexidine
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Moisturizing Gel
Other Intervention Name(s)
Veramin
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Oral care using Cotton swab dipped in 0.2% Chlorhexidine
Intervention Description
This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene
Primary Outcome Measure Information:
Title
Incidence of Ventilator-Associated Pneumonia (VAP)
Description
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.
Time Frame
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.
Secondary Outcome Measure Information:
Title
Duration of ICU Stay
Description
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
Time Frame
These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.
Title
Mortality Rates
Description
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.
Time Frame
These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akash Samuel, MS Nursing
Phone
03421532346
Email
akashsamuel20@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akash Samuel, MS Nursing
Organizational Affiliation
University of Health Sciences Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akash Samuel, MS Nursing

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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