Thirst in Intensive Care Unit (ICU) PracticeSEDENCT07157917
Thirst Translation and RCT
A study testing Protocol based in people with Thirst in Intensive Care Unit (ICU) Practice, run by National Taiwan University at 1 site in Taiwan.
Trial summary
To translate the SEDE-E (Extubated) and SEDE-T(tracheotomized) protocols-Chinese version and validate it with an RCT trial Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thirst in Intensive Care Unit (ICU) Practice
- What is being tested?
- Protocol based
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose physicians have issued orders for removal of the endotracheal tube or who have undergone tracheotomy,
- patients with clear consciousness
- patients who can communicate in Chinese as their native language
Who cannot join
- patients with water restriction
- patients who have undergone thirst quenching intervention measurements in the recovery room.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Translation and Application of the Chinese Thirst Safety Management Protocol: A Randomized Controlled Trial With Cultural Equivalence Validation Between Taiwan and Brazil
To translate the SEDE-E (Extubated) and SEDE-T(tracheotomized) protocols-Chinese version and validate it with an RCT trial
- Being tested
- Protocol based, Control
- Keywords
- Thirst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol basedOther
Apply a thirst safety management protocol
ControlOther
Room air water
| Study group | Role | What they receive |
|---|---|---|
| SEDE Group | Experimental | Intervene with a thirst management protocol Receives: Other: Protocol based |
| Usual care control | Placebo comparator | Room temperature water if needed Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirst intensity visual analogue scales
This is a 0~10 point Likert scale, with 0 indicates no thirsty, and 10 indicates the most severe thirsty.
Measured: 0, 15, 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thirst in Intensive Care Unit (ICU) PracticeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Principal investigator, Han-Yi Tsai, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157917
- Sponsor's protocol ID
- 202508163RIN
- Acronym
- SEDE
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient private consideration
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Application of the Chinese Thirst Safety Management Protocol: A Randomized Controlled Trial With Cultural Equivalence Validation Between Taiwan and Brazil
- ClinicalTrials.gov ID
- NCT07157917
- Acronym / sponsor ID
- SEDE / 202508163RIN
- Keywords
- Thirst
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Sep 2025 (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.
To translate the SEDE-E (Extubated) and SEDE-T(tracheotomized) protocols-Chinese version and validate it with an RCT trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEDE Group | Experimental | Other: Protocol basedIntervene with a thirst management protocol |
| Usual care control | Placebo comparator | Other: ControlRoom temperature water if needed |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose physicians have issued orders for removal of the endotracheal tube or who have undergone tracheotomy,
- patients with clear consciousness
- patients who can communicate in Chinese as their native language
Key exclusion criteria (2 listed)
- patients with water restriction
- patients who have undergone thirst quenching intervention measurements in the recovery room.
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 |
|---|---|---|
| Protocol basedApply a thirst safety management protocol | Other | SEDE Group |
| ControlRoom air water | Other | Usual care control |
Primary outcome
Thirst intensity visual analogue scales
Time frame: 0, 15, 60 minutes
This is a 0~10 point Likert scale, with 0 indicates no thirsty, and 10 indicates the most severe thirsty.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Patient private consideration
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol based in people with Thirst in Intensive Care Unit (ICU) Practice, run by National Taiwan University 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: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thirst intensity visual analogue scales (time frame: 0, 15, 60 minutes). 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 13 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.