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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06412627
Other study ID # 231234
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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