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Impact of Oral Care on Ventilator Associated Pneumonia

NCT ID: NCT07287566

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2025-07-15

Brief Summary

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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

Detailed Description

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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.

Conditions

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Ventilator Associated Pneumonia ( VAP)

Keywords

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oral hygiene ventilator associated pneumonia chlorohexidine mechanical ventilation pediatric intensive care unit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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intervention group

Toothbrushing + Chlorohexidine

Group Type EXPERIMENTAL

Toothbrushing + Chlorhexidine

Intervention Type PROCEDURE

three times daily for 5 minutes

control group

Routine oral care + Chlorohexidine

Group Type ACTIVE_COMPARATOR

Routine oral care + Chlorohexidine

Intervention Type PROCEDURE

three times daily for 5 minutes

Interventions

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Toothbrushing + Chlorhexidine

three times daily for 5 minutes

Intervention Type PROCEDURE

Routine oral care + Chlorohexidine

three times daily for 5 minutes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* primary immune deficiency coagulation disorders jaw fractures
Minimum Eligible Age

18 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed R. Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Pediatric Intensive Care Units, Children Hospital, Ain shams university

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 28143414 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://doi.org/10.1016/j.ejccm.2017.11.002

The Egyptian Journal of Critical Care Medicine. 5(3):87-91.

https://pubmed.ncbi.nlm.nih.gov/34091899/

Prevention of VAP: Endless evolving evidences-systematic literature review.

Other Identifiers

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FMA MS407 /2024

Identifier Type: OTHER

Identifier Source: secondary_id

FMASU MS407 /2024

Identifier Type: -

Identifier Source: org_study_id