Back to resultsThe Feasibility Study of Dual-Section Nasogastric Tube
Primary Purpose
Stroke, Mouth Neoplasms
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
two-piece nasogastric tube
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- dysphagia
- mouth neoplasms
- stroke
- already use conventional nasogastric tube for at least 2 weeks
Exclusion Criteria:
- unconsciousness patient
- unstable medical condition with needs of closely medical care
- unable to fill in inform consent
- the fixed length was less than 50 or more than 60 centimeter when using conventional nasogastric tube
Sites / Locations
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events
monitor the adverse events like pressure sore, numbers of self-extubation, dislocation of tube, or other unpredictable events.
Secondary Outcome Measures
satisfaction of Dual-Section Nasogastric Tube
using Likert scale for overall satisfaction
Full Information
NCT ID
NCT01649349
First Posted
June 29, 2012
Last Updated
July 22, 2012
Sponsor
Changhua Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01649349
Brief Title
The Feasibility Study of Dual-Section Nasogastric Tube
Official Title
The Feasibility Study of Dual-Section Nasogastric Tube in Dysphagia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this studyis to assess the feasibility and safety of novel designed two-piece nasogastric tube.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Mouth Neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
two-piece nasogastric tube
Intervention Description
one week period
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
monitor the adverse events like pressure sore, numbers of self-extubation, dislocation of tube, or other unpredictable events.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 weeks
Secondary Outcome Measure Information:
Title
satisfaction of Dual-Section Nasogastric Tube
Description
using Likert scale for overall satisfaction
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
dysphagia
mouth neoplasms
stroke
already use conventional nasogastric tube for at least 2 weeks
Exclusion Criteria:
unconsciousness patient
unstable medical condition with needs of closely medical care
unable to fill in inform consent
the fixed length was less than 50 or more than 60 centimeter when using conventional nasogastric tube
12. IPD Sharing Statement
Learn more about this trial
The Feasibility Study of Dual-Section Nasogastric Tube
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