Tokyo, Feb. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060544) titled 'Evaluation of the Efficacy of a Thirst Care Bundle for Tracheally Intubated Patients' on Feb. 1.

Study Type: Interventional

Study Design: Basic Design - n-of-1 Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Sapporo medical university

Condition: Condition - Intubated patient Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to clarify the change in the effect on thirst sensation by introducing a thirst care bundle compared to conventional thirst care in patients undergoing oral intubation during ICU admission, using a before-and-after comparative study. The results of this study suggest that establishing effective care methods for the thirst reported by orally intubated patients in the ICU could not only alleviate this discomfort but also potentially prevent complications like delirium, where thirst acts as an inducing or aggravating factor. This is considered an important finding that could lead to improved patient quality of life (QOL) and enhanced patient safety management. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention consisted of applying approximately 3 g of an oral moisturizing gel to the entire oral mucosa using a swab after routine oral care, and massaging the oral cavity with frozen, solution-impregnated oral swabs containing glycerin, sorbitol, and peppermint essence. A menthol-containing lip balm was applied to the lips in a 1 to 2 mm layer, and a nonwoven mask was worn over the mouth to prevent oral dryness (kept on at all times except during oral care and communication). The solution-impregnated swabs and lip balm were provided without a limit upon the patient's request. Before each oral care session, thirst was assessed using a 0 to 10 numeric rating scale, and before the pre-6 a.m. oral care session, oral moisture was measured with a moisture checker and oral dryness was evaluated using the Revised Oral Assessment Guide. The duration of oral care and the number of swabs used were recorded. The intervention was continued throughout the intubation period, and discontinued if deepened sedation made NRS assessment infeasible.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Eligible participants are ICU patients aged 18 years or older who are orally intubated, have a Richmond Agitation-Sedation Scale (RASS) score of 0 to -2, and can communicate verbally in some form, such as using a communication board. Key exclusion criteria - Patients are excluded if any of the following apply: severe oral mucosal or lip lesions preventing routine oral care; inability to perform oral cleansing; trismus limiting oral care; impaired consciousness or otherwise difficult communication; Glasgow Coma Scale score <10; inability to communicate nonverbally; nausea or vomiting; inability to self-report; clear refusal to participate; or an active Do Not Attempt Resuscitation (DNAR) order. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 15 Day Date of IRB - 2025 Year 05 Month 15 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069257

Disclaimer: Curated by HT Syndication.