NCT07157917

Brief Summary

To translate the SEDE-E (Extubated) and SEDE-T(tracheotomized) protocols-Chinese version and validate it with an RCT trial

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

August 28, 2025

Last Update Submit

April 7, 2026

Conditions

Thirst in Intensive Care Unit (ICU) Practice

Keywords

Thirst

Outcome Measures

Primary Outcomes (1)

  • 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.

    0, 15, 60 minutes

Study Arms (2)

SEDE Group

EXPERIMENTAL

Intervene with a thirst management protocol

Other: Protocol based

Usual care control

PLACEBO COMPARATOR

Room temperature water if needed

Other: Control

Interventions

Protocol basedOTHER

Apply a thirst safety management protocol

SEDE Group
ControlOTHER

Room air water

Usual care control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with water restriction
  • patients who have undergone thirst quenching intervention measurements in the recovery room.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taipei Medical University, School of Nursing, College of Nursing

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Patient private consideration

Locations

TW(1)