Trial Outcomes & Findings for The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia. (NCT NCT06039995)
NCT ID: NCT06039995
Last Updated: 2026-01-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Five days after initiation of the assigned oral care intervention.
Results posted on
2026-01-27
Participant Flow
Participant milestones
| Measure |
(Adjuvant Oral Care) Intervention Group
The intervention arm of the study focuses on evaluating the effectiveness of comprehensive oral care in reducing Ventilator-Associated Pneumonia (VAP) and improving patient outcomes. Patients in this group receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and moisturizing gel application.
The oral care strategies include:
Chlorhexidine Mouthwash: Known for its role in maintaining oral hygiene, this antiseptic rinse helps reduce bacterial load in the oral cavity.
Toothbrushing: Mechanical toothbrushing using 0.2% Chlorhexidine ensures thorough cleaning of teeth and surrounding tissues, enhancing oral hygiene.
Moisturizing Gel Application: Applied to both interior and exterior oral surfaces, this gel helps maintain moisture levels and prevent tissue dryness.
These interventions go beyond standard oral care, aiming to minimize the risk of VAP and improve patient health in the ICU.
|
(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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia.
Baseline characteristics by cohort
| Measure |
(Adjuvant Oral Care) Intervention Group
n=50 Participants
The intervention arm of the study focuses on evaluating the effectiveness of comprehensive oral care in reducing Ventilator-Associated Pneumonia (VAP) and improving patient outcomes. Patients in this group receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and moisturizing gel application.
The oral care strategies include:
Chlorhexidine Mouthwash: Known for its role in maintaining oral hygiene, this antiseptic rinse helps reduce bacterial load in the oral cavity.
Toothbrushing: Mechanical toothbrushing using 0.2% Chlorhexidine ensures thorough cleaning of teeth and surrounding tissues, enhancing oral hygiene.
Moisturizing Gel Application: Applied to both interior and exterior oral surfaces, this gel helps maintain moisture levels and prevent tissue dryness.
These interventions go beyond standard oral care, aiming to minimize the risk of VAP and improve patient health in the ICU.
|
(Traditional Oral Care) Control Group
n=50 Participants
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
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=41 Participants
|
50 Participants
n=1581 Participants
|
100 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Continuous
|
48.71 years
STANDARD_DEVIATION 10.54 • n=41 Participants
|
48.83 years
STANDARD_DEVIATION 11.6 • n=1581 Participants
|
48.77 years
STANDARD_DEVIATION 11.025 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=41 Participants
|
24 Participants
n=1581 Participants
|
49 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=41 Participants
|
26 Participants
n=1581 Participants
|
51 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
50 Participants
n=41 Participants
|
50 Participants
n=1581 Participants
|
100 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
Pakistan
|
50 participants
n=41 Participants
|
50 participants
n=1581 Participants
|
100 participants
n=4626 Participants
|
|
Number of Participants with Ventilator Associated Pneumonia
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Five days after initiation of the assigned oral care intervention.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.
Outcome measures
| Measure |
(Adjuvant Oral Care) Intervention Group
n=50 Participants
This group constitutes the intervention arm of the study. Patients assigned to this arm receive comprehensive oral care consisting of chlorhexidine mouthwash, mechanical toothbrushing, and application of moisturizing gel to both the interior and exterior surfaces of the oral cavity. The purpose of this intervention is to evaluate the effectiveness of enhanced oral care as an adjunct strategy in reducing the incidence of ventilator-associated pneumonia (VAP) and improving patient outcomes in the intensive care unit (ICU).
Components of the Intervention
Chlorhexidine Mouthwash (0.2%) Patients receive 0.2% chlorhexidine mouthwash, an established antimicrobial agent used to reduce oral microbial load and maintain oral hygiene.
Mechanical Toothbrushing Toothbrushing is performed to mechanically remove dental plaque and debris from the teeth and surrounding oral tissues, ensuring thorough oral hygiene beyond chemical disinfection alone.
Moisturizing Gel Application A moisturizing gel is applied to the interior and exterior surfaces of the oral cavity to prevent oral dryness and maintain mucosal integrity.
Together, these interventions provide a comprehensive oral care regimen designed to enhance standard care practices, reduce bacterial colonization, and potentially lower the risk of VAP while improving overall patient comfort and clinical outcomes.
|
(Traditional Oral Care) Control Group
n=50 Participants
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
|
|---|---|---|
|
Incidence of Ventilator-Associated Pneumonia (VAP)
|
16 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.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
Outcome measures
| Measure |
(Adjuvant Oral Care) Intervention Group
n=50 Participants
This group constitutes the intervention arm of the study. Patients assigned to this arm receive comprehensive oral care consisting of chlorhexidine mouthwash, mechanical toothbrushing, and application of moisturizing gel to both the interior and exterior surfaces of the oral cavity. The purpose of this intervention is to evaluate the effectiveness of enhanced oral care as an adjunct strategy in reducing the incidence of ventilator-associated pneumonia (VAP) and improving patient outcomes in the intensive care unit (ICU).
Components of the Intervention
Chlorhexidine Mouthwash (0.2%) Patients receive 0.2% chlorhexidine mouthwash, an established antimicrobial agent used to reduce oral microbial load and maintain oral hygiene.
Mechanical Toothbrushing Toothbrushing is performed to mechanically remove dental plaque and debris from the teeth and surrounding oral tissues, ensuring thorough oral hygiene beyond chemical disinfection alone.
Moisturizing Gel Application A moisturizing gel is applied to the interior and exterior surfaces of the oral cavity to prevent oral dryness and maintain mucosal integrity.
Together, these interventions provide a comprehensive oral care regimen designed to enhance standard care practices, reduce bacterial colonization, and potentially lower the risk of VAP while improving overall patient comfort and clinical outcomes.
|
(Traditional Oral Care) Control Group
n=50 Participants
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
|
|---|---|---|
|
Duration of ICU Stay
|
12.28 Days
Standard Deviation 7.15
|
11.19 Days
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.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.
Outcome measures
| Measure |
(Adjuvant Oral Care) Intervention Group
n=50 Participants
This group constitutes the intervention arm of the study. Patients assigned to this arm receive comprehensive oral care consisting of chlorhexidine mouthwash, mechanical toothbrushing, and application of moisturizing gel to both the interior and exterior surfaces of the oral cavity. The purpose of this intervention is to evaluate the effectiveness of enhanced oral care as an adjunct strategy in reducing the incidence of ventilator-associated pneumonia (VAP) and improving patient outcomes in the intensive care unit (ICU).
Components of the Intervention
Chlorhexidine Mouthwash (0.2%) Patients receive 0.2% chlorhexidine mouthwash, an established antimicrobial agent used to reduce oral microbial load and maintain oral hygiene.
Mechanical Toothbrushing Toothbrushing is performed to mechanically remove dental plaque and debris from the teeth and surrounding oral tissues, ensuring thorough oral hygiene beyond chemical disinfection alone.
Moisturizing Gel Application A moisturizing gel is applied to the interior and exterior surfaces of the oral cavity to prevent oral dryness and maintain mucosal integrity.
Together, these interventions provide a comprehensive oral care regimen designed to enhance standard care practices, reduce bacterial colonization, and potentially lower the risk of VAP while improving overall patient comfort and clinical outcomes.
|
(Traditional Oral Care) Control Group
n=50 Participants
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
|
|---|---|---|
|
Mortality Rates
|
22 Participants
|
33 Participants
|
Adverse Events
(Adjuvant Oral Care) Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths
(Traditional Oral Care) Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 33 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place