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Not yet recruitingNCT06412627Updated May 14, 2024

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

An interventional study of 4°C frozen normal saline gauze in Endotracheal Tube, Thirst and Dry Mouth, sponsored by Changhua Christian Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endotracheal Tube
  • Thirst
  • Dry Mouth

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Keywords

  • dry mouth
  • thirst
  • endotracheal tube
03

In context

Xerostomia

254 studies on the registry are indexed under Xerostomia; 47 are open to participants now.

This study's planned enrollment of 100 is above the median of 42 across 216 interventional studies indexed under Xerostomia.

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Lead sponsor

Changhua Christian Hospital is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of head and neck cancer.
  • Oral mucosal damage, swelling, or bleeding that precludes placement of a moist gauze pad.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    control group

    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
    experimental group

    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

  • Procedure4°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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

1 site
  • Changhua Christian Hospital
    Changhua, 50006, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06412627
Lead sponsor
Changhua Christian Hospital
Responsible party
Sponsor
First posted
May 14, 2024
Start date
May 2024 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
Jan 2025 (estimated)
Last update
May 14, 2024

Study contacts

Kuan Wen Lai
Contact
luke801458@gmail.com
+88647238595 ext. 5901

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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