## Protocol Section
### Identification Module
**NCT ID:** NCT06412627

**Brief Title:** The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube

**Official Title:** The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube

#### Organization Study ID Info
**ID:** 231234
#### Organization
**Class:** OTHER
**Full Name:** Changhua Christian Hospital
### Status Module
#### Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Changhua Christian Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Long-term placement of endotracheal tubes often causes discomfort, including lip ulcers, laryngeal pain, and dry oral mucosa, leading to frequent complaints of dry mouth and thirst among conscious patients. However, these symptoms are commonly overlooked in the nursing process, resulting in emotional distress and irritability in patients. Although healthcare providers recognize the issue of dry mouth and thirst in patients with endotracheal tubes, effective management is challenging due to concerns about treatment limitations, aspiration pneumonia, and the risk of coughing or vomiting. This experimental study aims to explore the effectiveness of using 4°C frozen gauze soaked in normal saline to relieve dry mouth and thirst in patients with endotracheal tubes.

### Conditions Module

**Conditions:**

- Endotracheal Tube

- Thirst

- Dry Mouth

**Keywords:**

- dry mouth

- thirst

- endotracheal tube

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Label:** control group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: 4°C frozen normal saline gauze

**Label:** experimental group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- experimental group

**Description:** 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.

**Name:** 4°C frozen normal saline gauze

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Oral moisture checking device

**Time Frame:** Change from baseline dry mouth at Day 3, and Day 7

#### Secondary Outcomes

**Description:** The Oral health assessment Tool consists of 8 categories: lips, tongue, gum and tissues, saliva, natural teeth, dentures, oral cleanliness, and dental pain. The scoring is as follows: 0 points for "healthy," 1 point for "beginning changes in the mouth," and 2 points for "unhealthy." The maximum score is 16, with higher scores indicating poorer oral health.

**Measure:** Oral health assessment Tool

**Time Frame:** Change from baseline oral health status at Day 3, and Day 7

**Description:** The bedside oral examination scale comprises 8 categories: swallow, lips, tongue, mucous membranes, saliva, gingiva, teeth or dentures, and odor. Each category is scored as follows: 1 point for "severe dysfunction," 2 points for "moderate dysfunction," and 3 points for "normal." A total score of 24 indicates a normal oral health status, while a score of 8 indicates severe oral health dysfunction.

**Measure:** Bedside oral examination scale

**Time Frame:** Change from baseline oral health function at Day 3, and Day 7

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** luke801458@gmail.com

**Name:** Kuan Wen Lai

**Phone:** +88647238595

**Phone Ext:** 5901

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Changhua

**Country:** Taiwan

**Facility:** Changhua Christian Hospital

**Zip:** 50006

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012466

- Term: Salivary Gland Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17724

- Name: Xerostomia

- Relevance: HIGH

- As Found: Dry Mouth

- ID: M15285

- Name: Salivary Gland Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014987

- Term: Xerostomia

### Misc Info Module

- Version Holder: 2024-05-31
