Tokyo, April 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061190) titled 'Efficacy of Oral Care with MA-T in Preventing Ventilator-Associated Pneumonia in Intubated ICU Patients' on April 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Tokyo Science University Hospital
Condition:
Condition - Intubated patients in the intensive care unit
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate whether oral care using MA-T reduces the incidence of ventilator-associated pneumonia (VAP) compared with conventional oral care in intubated patients admitted to the ICU
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral care with conventional oral care kit mouthwash (6 ml) and mouth paste (2 g) for brushing.
Interventions/Control_2 - Oral care using MA-T mouthwash (6 ml) and MA-T oral gel (2 g) for brushing, in place of conventional mouthwash and mouth paste.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients intubated and receiving mechanical ventilation
Key exclusion criteria - Patients extubated within 48 hours of intubation
Patients with oral or facial trauma
Patients at risk of oral bleeding due to coagulopathy, oral ulcers, or other conditions that may be exacerbated by frequent oral care
Patients capable of performing oral care independently
Patients with pneumonia as the primary diagnosis at admission
Target Size - 200
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 01 Month 27 Day
Date of IRB - 2026 Year 01 Month 27 Day
Anticipated trial start date - 2026 Year 03 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070025
Disclaimer: Curated by HT Syndication.