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

Dry Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412627
• Other study ID #: 231234
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Changhua Christian Hospital
• Contact: Kuan Wen Lai
• Phone: +88647238595
• Email: luke801458[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Mouth
• Endotracheal Tube
• Thirst
• Xerostomia

Intervention

Procedure:
• 4°C frozen normal saline gauze
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.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oral health assessment Tool	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.	Change from baseline oral health status at Day 3, and Day 7
Secondary	Bedside oral examination scale	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.	Change from baseline oral health function at Day 3, and Day 7