Clinical Research Directory

Effectiveness of Enzyme Spray Intervention on Thirst Relief in Patients With Endotracheal Intubation.

Sponsor: Yeh,Shiao Feng

Summary

Thirst is a common and distressing symptom among intensive care unit (ICU) patients with endotracheal intubation. Endotracheal intubation, nil per os (NPO) status, oxygen therapy, and medication effects may contribute to oral dryness and thirst. Current approaches such as water or saline sprays may provide only short-term relief, and direct oral water administration may increase the risk of choking or aspiration. Enzyme-based saliva substitutes may help maintain oral moisture by mimicking components of natural saliva, but evidence in ICU populations remains limited. This randomized controlled trial with blinded outcome assessment was conducted in a surgical ICU at a medical center in southern Taiwan. Adults aged ≥18 years with endotracheal intubation expected to exceed 24 hours, a baseline thirst intensity score (NRS-I) ≥3, and the ability to communicate were eligible. A total of 76 participants were randomly assigned in a 1:1 ratio to either an enzyme-based oral spray group or a distilled-water control group. Allocation concealment was achieved using sequentially numbered, opaque, sealed envelopes (SNOSE). Following routine oral care, both interventions were administered using identical opaque spray bottles and standardized procedures. Twelve sprays (approximately 1.56 mL) were applied to four standardized intraoral sites. The co-primary outcomes were thirst intensity (NRS-I) and thirst distress (NRS-D), assessed at baseline and 30, 60, 120, and 240 minutes post-intervention by trained outcome assessors blinded to group allocation. Generalized estimating equations (GEE) were used to evaluate group, time, and group-by-time interaction effects while accounting for correlations among repeated measurements. Predefined safety criteria required discontinuation of the intervention if clinically significant discomfort, choking, respiratory deterioration, or other adverse events occurred.

Official title: Effectiveness of Enzyme Spray Intervention on Thirst Relief in Patients With Endotracheal Intubation

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