The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia.
NCT ID: NCT06039995
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-08-02
2024-12-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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(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.
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).
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.
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.
(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.
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.
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
Interventions
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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).
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.
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.
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MCPIS score between 0 to 5 on first day of admission at ICU
Exclusion Criteria
* Previous history of respiratory illness.
* Immunocompromised.
* Ongoing sepsis.
* Pregnancy.
* Presence of dentures.
18 Years
65 Years
ALL
No
Sponsors
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University of Health Sciences Lahore
OTHER
Responsible Party
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Akash Samuel
Principal Investigator
Principal Investigators
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Akash Samuel, MS Nursing
Role: PRINCIPAL_INVESTIGATOR
University of Health Sciences Lahore
Locations
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University of Health Sciences
Lahore, Punjab Province, Pakistan
Services Hospital
Lahore, , Pakistan
Countries
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Central Contacts
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Facility Contacts
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Akash Samuel, MS Nursing
Role: primary
Recruiment Focal Person
Role: primary
Other Identifiers
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VAP RCT 23
Identifier Type: -
Identifier Source: org_study_id