Impact of Oral Care on Ventilator Associated Pneumonia (OH-VAP)

The Impact of Different Methods of Oral Hygiene on Incidence of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit

The goal of this clinical trial was to find out whether cleaning the mouths of children in the Pediatric Intensive Care Unit (PICU) with toothbrushing and chlorhexidine lowers the chance of getting lung infections in patients on breathing machines compared to routine mouth care. The study determined whether this approach changed how long children need a breathing machine, how many days they stayed in the PICU, and whether it affects survival. The main questions it aimed to answer were:

• Did toothbrushing with chlorhexidine, compared to routine mouth care, lowered the risk of lung infections in patients on breathing machines in the PICU?
• Did this approach also affect recovery outcomes, including duration of needing a breathing machine, length of PICU stay, and survival rates?

Researchers compared toothbrushing and chlorhexidine to routine mouth care to see if toothbrushing and chlorhexidine lowered the risk of lung infections in patients on breathing machines.

Participants:

Had safety practices to prevent lung infections in patients on breathing machines Had toothbrushing and chlorhexidine or routine mouth care three times daily 5 minutes in each Had physical check-up and any tests needed as part of their care

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia ( VAP)
• Intervention / Treatment: Procedure: Toothbrushing + Chlorhexidine; Procedure: Routine oral care + Chlorohexidine

Detailed Description

Pediatric dentist trained the nurses to follow the proper oral care protocol. Safe practices as keeping the patient's head slightly raised while lying in bed and clean the patients mouth regularly to remove germs. Participants and researcher didn't know which oral care method was being administered making this double blinded study. The participants were divided into two groups 59 patients in each group. In Tooth brushing group, tooth paste and soft tooth brush was positioned at 45 degree angle with a firm gentle pressure, brushing back and forth or using a circular motion 15 to 20 times before moving to the next area for one minute plus application of chlorhexidine mouthwash to a swab on the oral mucosa, teeth, gums, hard palate, and tongue, followed by 20 milliliter (mL) of normal saline, the procedure was finished with hypo pharyngeal suctioning. In routine oral care group only a swab with chlorhexidine and rubbing it on the surface of the tongue, gum and mucosa followed by 20 mL of normal saline, the procedure was finished with hypo pharyngeal suctioning.

investigations include laboratory (Complete blood picture, C-reactive protein and Venous blood gases (VBG) were done. Radiological and microbiological included sputum culture collected on fifth day were also done.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 00002
    • Pediatric Intensive Care Units, Children Hospital, Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: dentate mechanically ventilated

-

Exclusion Criteria:

• primary immune deficiency coagulation disorders jaw fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Toothbrushing + Chlorohexidine	Procedure: Toothbrushing + Chlorhexidine; three times daily for 5 minutes
Active Comparator: control group; Routine oral care + Chlorohexidine	Procedure: Routine oral care + Chlorohexidine; three times daily for 5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of VAP in pediatric patients in PICU receiving toothbrushing and chlorohexidine in comparison to routine oral hygiene	number of patients who develop VAP	Baseline, Day 2, Day3, Day 4 and Day 5 of enrollment

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ahmed R. Ahmed, MD, Ain Shams University

Publications and helpful links

General Publications

• de Lacerda Vidal CF, Vidal AK, Monteiro JG Jr, Cavalcanti A, Henriques APC, Oliveira M, Godoy M, Coutinho M, Sobral PD, Vilela CA, Gomes B, Leandro MA, Montarroyos U, Ximenes RA, Lacerda HR. Impact of oral hygiene involving toothbrushing versus chlorhexidine in the prevention of ventilator-associated pneumonia: a randomized study. BMC Infect Dis. 2017 Jan 31;17(1):112. doi: 10.1186/s12879-017-2188-0.

Helpful Links

• The Egyptian Journal of Critical Care Medicine. 5(3):87-91.
• Prevention of VAP: Endless evolving evidences-systematic literature review.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: mechanical ventilation; ventilator associated pneumonia; oral hygiene; pediatric intensive care unit; chlorohexidine
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Pneumonia, Ventilator-Associated; Organic Chemicals; Biguanides; Guanidines; Amidines; Dentistry; Preventive Dentistry; Oral Hygiene; Chlorhexidine; Toothbrushing
• Other Study ID Numbers: FMASU MS407 /2024; FMA MS407 /2024 (Other Identifier: Research Ethics Committee-Faculty of Medicine-ASU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No