Endotracheal TubeNCT06412627
The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube
A study testing 4°C frozen normal saline gauze in people with Endotracheal Tube and Thirst, run by Changhua Christian Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Tube, Thirst, Dry Mouth
- What is being tested?
- 4°C frozen normal saline gauze
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endotracheal intubation.
- Aged 18 years or older.
- Patient or family members are willing to sign the consent form.
Who cannot join
- History of head and neck cancer.
- Oral mucosal damage, swelling, or bleeding that precludes placement of a moist gauze pad.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Endotracheal Tube, Thirst, Dry Mouth
- Being tested
- 4°C frozen normal saline gauze
- Keywords
- dry mouth, thirst, endotracheal tube
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4°C frozen normal saline gauzeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 4°C frozen normal saline gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline dry mouth at Day 3, and Day 7
Secondary outcomes (2)
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.
Measured: Change from baseline oral health status at Day 3, and Day 7
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.
Measured: Change from baseline oral health function at Day 3, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study startMay 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal TubeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412627
- Sponsor's protocol ID
- 231234
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube
- ClinicalTrials.gov ID
- NCT06412627
- Acronym / sponsor ID
- 231234
- Conditions
- Endotracheal Tube, Thirst, Dry Mouth
- Keywords
- dry mouth, thirst, endotracheal tube
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: 4°C frozen normal saline gauzeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Endotracheal intubation.
- Aged 18 years or older.
- Patient or family members are willing to sign the consent form.
Key exclusion criteria (2 listed)
- History of head and neck cancer.
- Oral mucosal damage, swelling, or bleeding that precludes placement of a moist gauze pad.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4°C frozen normal saline gauzeSoak 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. | Procedure or surgery | experimental group |
Primary outcome
Oral moisture checking device
Time frame: Change from baseline dry mouth at Day 3, and Day 7
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.
2 secondary outcomes
Oral health assessment Tool
Time frame: Change from baseline oral health status at Day 3, and Day 7
Bedside oral examination scale
Time frame: Change from baseline oral health function at Day 3, and Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4°C frozen normal saline gauze in people with Endotracheal Tube and Thirst, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuan Wen Lai (+88647238595 ext. 5901, luke801458@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral moisture checking device (time frame: Change from baseline dry mouth at Day 3, and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.