Pneumonia, Ventilator-AssociatedNCT06039995
The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia.
A study testing Comprehensive Oral Care, Traditional Oral Care and Mechanical Tooth Brushing using 0.2% Chlorhexidine in people with Pneumonia, Ventilator-Associated, run by University of Health Sciences Lahore at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Comprehensive Oral Care, Traditional Oral Care and Mechanical Tooth Brushing using 0.2% Chlorhexidine
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Aug 2024to 15 Jan 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- More than 48 hours of mechanical ventilation before ICU admission.
- Previous history of respiratory illness.
- Immunocompromised.
- Ongoing sepsis.
- Pregnancy.
- Presence of dentures.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
University of Health Sciences
Lahore, Punjab Province, 54000
Services Hospital
Lahore
About this study
Official title: The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia: A Randomized Controlled Trial.
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:
Read more
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.
Read the 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.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- 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
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Oral CareProcedure or surgery
Also called Adjuvant oral care as a component of traditional 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 CareProcedure or surgery
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% ChlorhexidineDevice
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 GelDevice
Also called Veramin
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% ChlorhexidineDevice
This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene
| Study group | Role | What they receive |
|---|---|---|
| (Adjuvant Oral Care) Intervention Group | Experimental | 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. Receives: Procedure: Comprehensive Oral Care; Device: Mechanical Tooth Brushing using 0.2% Chlorhexidine; Device: Moisturizing Gel |
| (Traditional Oral Care) Control Group | Active comparator | 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. Receives: Procedure: Traditional Oral Care; Device: Oral care using Cotton swab dipped in 0.2% Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ventilator-Associated Pneumonia (VAP)
This outcome measures the number of participants who developed ventilator-associated pneumonia (VAP) within the early period following initiation of mechanical ventilation. VAP was assessed using clinical and diagnostic criteria on the fifth day after implementation of the assigned oral care intervention. This outcome was used to evaluate the effectiveness of adjuvant oral care compared with traditional oral care in preventing early-onset VAP.
Measured: Five days after initiation of the assigned oral care intervention.
Secondary outcomes (2)
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
Measured: These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.
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.
Measured: These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Aug 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akash Samuel, University of Health Sciences Lahore
- Investigators
- Akash Samuel, MS Nursing, Principal investigator, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039995
- Sponsor's protocol ID
- VAP RCT 23
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2023
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No