The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube

NCT06412627 | Not Yet Recruiting

• 1 other identifier: 231234
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an experimental study aimed at exploring the effectiveness of using 4°C frozen gauze with normal saline for relieving dry mouth and thirst in patients with endotracheal tubes.

Conditions

Endotracheal Tube; Thirst; Dry Mouth

Keywords

dry mouth; thirst; endotracheal tube

Outcome Measures

Primary Outcomes (1)

• Oral moisture checking device

  The oral moisture checking device was utilized to assess symptoms of dry mouth in participants. This study utilized an oral moisture checking device produced by Life Co., Ltd. of Japan, which measures the moisture content within the oral cavity using the principle of bioelectrical impedance analysis (BIA). The measurement method involves placing a specialized plastic sleeve over the tongue approximately one centimeter from the tip and applying a force of 200 grams. A measurement is obtained after about 2 seconds. A reading below 27.9 indicates dryness, a reading between 28 and 29.5 is considered borderline, and readings of 29.6 and above are normal. Both the sensitivity and specificity of this method are 0.8.

  Change from baseline dry mouth at Day 3, and Day 7

Secondary Outcomes (2)

• Oral health assessment Tool

  Change from baseline oral health status at Day 3, and Day 7

• Bedside oral examination scale

  Change from baseline oral health function at Day 3, and Day 7

Study Arms (2)

control group

NO INTERVENTION

The control group received only usual care, while the Oral moisture checker (Mucus, Life Co., Ltd.), the Oral Health Assessment Tool, and the Bedside Oral Exam were used to assess oral mucosal moisture and oral health status before (day 0) and after 7 days.

experimental group

EXPERIMENTAL

The experimental group had 4°C saline-soaked gauze applied to the oral cavity for 15 minutes at 06:00 AM and 06:00 PM daily for one week, while the Oral moisture checker (Mucus, Life Co., Ltd.), the Oral Health Assessment Tool, and the Bedside Oral Exam were used to assess oral mucosal moisture and oral health status before (day 0) and after 7 days.

Procedure: 4°C frozen normal saline gauze

Interventions

4°C frozen normal saline gauze PROCEDURE

Soak two 4x4 gauze pads in 15 ml of normal saline, refrigerate at 4°C, and then apply in the oral cavity for 15 minutes before removal.

experimental group

Eligibility Criteria

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

You may qualify if:

• Endotracheal intubation.
• Aged 18 years or older.
• Patient or family members are willing to sign the consent form.

You may not qualify if:

• History of head and neck cancer.
• Oral mucosal damage, swelling, or bleeding that precludes placement of a moist gauze pad.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Kuan Wen Lai

CONTACT

+88647238595; luke801458@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 14, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

TW (1)