Clinical trial NCT06039995: 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
Overall status: RECRUITING
Phase: NA
Conditions: Pneumonia, Ventilator-Associated
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Ventilator-Associated Pneumonia (VAP)
timeFrame: 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 outcomes:
measure: Duration of ICU Stay
timeFrame: These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.
measure: Mortality Rates
timeFrame: These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Health Sciences
state: Punjab
city: Lahore
country: Pakistan
facility: Services Hospital
Study officials:
affiliation: University of Health Sciences Lahore
name: Akash Samuel, MS Nursing
role: PRINCIPAL_INVESTIGATOR
References: