The Effect of an Suction Toothbrush on the Development of Ventilator-Associated Pneumonia

NCT ID: NCT07125495

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-12-20

Brief Summary

Literature suggests that suction toothbrushes may improve oral care in intubated patients by facilitating secretion removal and reducing microaspiration. This could decrease the need for endotracheal suctioning and lower the risk of ventilator-associated pneumonia (VAP). Therefore, this study aimed to examine the effect of a suction toothbrush on the development of VAP in intubated patients.

Detailed Description

in the literature examining the superiority of a suction toothbrush over another regarding the frequency of oral care practices, appropriate solution and material use in intubated patients. It is believed that a suction toothbrush will both facilitate oral care and clear oral secretions. By minimizing secretion accumulation in the mouth, it will prevent microaspiration and reduce the need for endotracheal suctioning in patients. Determining the most effective oral care method is expected to reduce the incidence of ventilator-associated pneumonia and positively impact patient mortality. Considering all this information, the aim of this study was to examine the effect of a suction toothbrush on the development of ventilator-associated pneumonia in intubated patients.

Conditions

Infection; Intensive Care (ICU); Intubation; Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Suction tootbrush + distilled water

All tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions.

Group Type: EXPERIMENTAL

Suction tootbrush and distiled water

Intervention Type: OTHER

All tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions.

Suction toothbrush + 0.12% chlorhexidine gluconate oral solution

Every 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care.

Group Type: ACTIVE_COMPARATOR

suction tootbrush and .12% chlorhexidine gluconate

Intervention Type: OTHER

Every 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care.

oral care sponge + 0.12% chlorhexidine gluconate oral solution

All tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) with an oral care sponge used in oral care.

Group Type: ACTIVE_COMPARATOR

Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution

Intervention Type: OTHER

All tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) and an oral care sponge used in oral care in the intensive care unit. After oral care, oropharyngeal secretions were aspirated.

Interventions

Suction tootbrush and distiled water

All tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions.

Intervention Type: OTHER

suction tootbrush and .12% chlorhexidine gluconate

Every 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care.

Intervention Type: OTHER

Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution

All tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) and an oral care sponge used in oral care in the intensive care unit. After oral care, oropharyngeal secretions were aspirated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients

• who aged over 18 years
• who underwent orotracheal intubation after admission to the ICU,
• who had no known pneumonia or diagnosis of pneumonia at the time of intubation,
• who were intubated for more than 48 hours,
• who had no microorganisms detected in the tracheal aspirate within the first 48 hours,
• who had no lesions on the oral mucous membrane before intubation,
• who had no known allergy to chlorhexidine were included in the study.

Exclusion Criteria

Patients

• who under 18 years of age,
• those with a tracheostomy,
• those were intubated for less than 48 hours,
• those with microorganisms detected in their tracheal aspirate within the first 48 hours,
• those who underwent reintubation,
• those were pregnant,
• those with lesions in the oral mucosa during intensive care admission,
• those with bleeding coagulation disorders or thrombocytopenia,
• those admitted to intensive care from an external institution while intubated, and those with a known chlorhexidine allergy were excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koç University Hospital

UNKNOWN

Sponsor Role: collaborator

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Ayda Kebapci

Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Koç University hospital Intensive care unit

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TootbrushICU

Identifier Type: -

Identifier Source: org_study_id