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

NCT07533552 | Active Not Recruiting

• 1 other identifier: CMMC11501-023
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enzyme-Based Oral Spray for Alleviating Thirst in Endotracheally Intubated Patients

Keywords

Enzyme-Based Oral Spray; Thirst

Outcome Measures

Primary Outcomes (1)

• Thirst Intensity (NRS-I)

  Thirst intensity measured using the Numerical Rating Scale for Thirst Intensity (NRS-I), ranging from 0 (no thirst) to 10 (worst possible thirst). Assessments will be conducted at baseline (T0) and at 30 minutes (T1), 60 minutes (T2), 120 minutes (T3), and 240 minutes (T4) post-intervention.

  Baseline (T0) to 240 minutes post-intervention

Secondary Outcomes (1)

• Thirst Distress (NRS-D)

  Baseline (T0) to 240 minutes post-intervention

Study Arms (2)

Enzyme-based Oral Spray Group

EXPERIMENTAL

Participants in this group will receive an enzyme-based oral spray (Oral7®) following routine oral care. The intervention will be administered using a standardized protocol, including application to four intraoral sites with a total of 12 sprays per session.

Other: Enzyme-based oral spray (Oral7®)

Distilled Water Spray Group

PLACEBO COMPARATOR

Participants in this group will receive distilled water oral spray administered at the same frequency, procedure, and time points as the experimental group following routine oral care.

Other: Distilled water oral spray

Interventions

Enzyme-based oral spray (Oral7®) OTHER

An enzyme-based saliva substitute containing bioactive components such as lysozyme and lactoperoxidase, designed to mimic natural saliva, enhance oral moisture retention, and stabilize the oral microenvironment.

Enzyme-based Oral Spray Group

Distilled water oral spray OTHER

Distilled water administered via oral spray to provide moisture to the oral cavity, serving as a comparator for the enzyme-based oral spray.

Distilled Water Spray Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yeh,Shiao Feng: lead

Study Sites (1)

Chi Mei Medical Center

Tainan, Tainan City, 710, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study adopts a single-blind design. Participants are blinded to group allocation, as both intervention solutions are colorless, odorless, and administered using identical opaque spray bottles. Outcome assessors are also blinded to group assignment to minimize measurement bias. No additional parties are masked beyond those specified.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Nurse

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

TW (1)