Active — Not RecruitingNot Applicable

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

Taiwan76 participantsStarted 2026-04-10

Plain-language summary

This study addresses the high prevalence (66%-70%) of thirst among intensive care unit (ICU) patients with endotracheal intubation, a symptom associated with oral mucosal dryness, nil per os (NPO) status, high-flow oxygen therapy, and medication effects. Unrelieved thirst may contribute to anxiety, delirium, and unplanned extubation. Current clinical practices, such as cold water or saline sprays, provide only transient relief and may pose aspiration risks. Enzyme-based saliva substitutes, which mimic natural saliva and stabilize the oral environment, show potential benefits; however, evidence in ICU populations remains limited. A single-blind randomized controlled trial (RCT) will be conducted in an ICU of a medical center in southern Taiwan. Eligible participants are adult patients (≥18 years) with endotracheal intubation expected to exceed 24 hours, a baseline thirst intensity score (NRS-I) ≥3, and the ability to communicate. A total of 76 participants will be recruited and randomly assigned in a 1:1 ratio to either the experimental group (enzyme-based oral spray) or the control group (distilled water spray), using sequentially numbered, opaque, sealed envelopes (SNOSE) to ensure allocation concealment. The intervention will be administered following routine oral care within a standardized time window (13:00-15:00). Both solutions will be prepared in identical opaque spray bottles to maintain blinding. The protocol includes 12 sprays per session (approximately 1.56 mL), delivered to four standardized intraoral sites, with outcomes monitored over a 4-hour period. Primary outcomes include thirst intensity (Numerical Rating Scale-Intensity, NRS-I) and thirst distress (Numerical Rating Scale-Distress, NRS-D), assessed at baseline (T0) and at 30, 60, 120, and 240 minutes post-intervention (T1-T4) by blinded outcome assessors. No biological specimens will be collected; data will be obtained from self-reported measures and electronic medical records, with strict de-identification and secure storage procedures. This study is considered minimal risk. Any adverse events, such as discomfort or choking, will result in immediate discontinuation of the intervention. Data will be analyzed using generalized estimating equations (GEE) to evaluate group, time, and interaction effects. The findings are expected to provide evidence-based guidance for improving thirst management, enhancing patient comfort, and optimizing the quality of critical care nursing.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients aged ≥18 years admitted to the intensive care unit (ICU) with endotracheal intubation, and an expected duration of intubation \>24 hours. * Thirst intensity score ≥3 on the Numerical Rating Scale for Thirst Intensity (NRS-I). * Conscious and able to communicate subjective sensations verbally (Mandarin or Taiwanese) or in written form. * Richmond Agitation-Sedation Scale (RASS) score between -1 and +1. * Willingness to participate and provision of written informed consent after a full explanation of the study. Exclusion Criteria: * Known allergy to enzyme spray components (e.g., lysozyme, lactoperoxidase, glucanase, xylitol). * Known allergy to milk or eggs. * Pre-existing xerostomia. * Presence of oral mucosal ulcers or active oral bleeding. * History of oral surgery. * Physician-diagnosed abnormal salivary secretion. * Physician-determined increased risk of aspiration or other complications associated with oral spray administration.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Thirst Intensity (NRS-I)

Timeframe: Baseline (T0) to 240 minutes post-intervention

Trial details

NCT IDNCT07533552

SponsorYeh,Shiao Feng

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Thirst trials