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

Pneumonia, Ventilator-Associated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06039995
• Other study ID #: VAP RCT 23
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: May 2024
• Source: University of Health Sciences Lahore
• Contact: Akash Samuel, MS Nursing
• Phone: 03421532346
• Email: akashsamuel20[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 15, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

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).
• 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:
• 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

Locations

Country	Name	City	State
Pakistan	University of Health Sciences	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Health Sciences Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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	These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.
Secondary	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.	These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.