Back to resultsExplore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion
Primary Purpose
Nasogastric Tube Esophagitis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fiberscope-Guided Nasogastric tube insertion
Sponsored by
About this trial
This is an interventional supportive care trial for Nasogastric Tube Esophagitis focused on measuring cancer patients, Nutritional status
Eligibility Criteria
Inclusion criteria: dysphagia patients who need nasogastric tube feeding Exclusion criteria: Patients who ever had human immunodeficiency virus infection and were not suitable for fiberscope exam without protection sheath
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fiberscope-Guided Nasogastric tube
Arm Description
Fiberscope-Guided Nasogastric tube insertion
Outcomes
Primary Outcome Measures
The success rates of fiberscope-guided NG tube insertion
fiberscope-guided NG tube insertion
Secondary Outcome Measures
Full Information
NCT ID
NCT03415451
First Posted
October 1, 2017
Last Updated
March 3, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03415451
Brief Title
Explore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion
Official Title
Explore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
For Head and neck cancer and uncooperative patients, blind nasogastric tube (NGT) insertion may sometimes be very difficult because of the anatomical obstructions in the pharynx and uncoordinated swallowing motion. To solve the problem, flexible endoscope has been used widely to assist the NGT insertion via direct visual assistance, working channels/guide wires, or suture fixation. Unfortunately, these tools are not easily assessed in the outpatient department. Here, we try to use a simpler method for the flexible endoscope to guide the NGT insertion.
Detailed Description
NGT and fiberscope was combined to facilitate NG tube insertion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasogastric Tube Esophagitis
Keywords
cancer patients, Nutritional status
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fiberscope-Guided Nasogastric tube
Arm Type
Experimental
Arm Description
Fiberscope-Guided Nasogastric tube insertion
Intervention Type
Device
Intervention Name(s)
Fiberscope-Guided Nasogastric tube insertion
Intervention Description
Fiberscope-Guided Nasogastric tube insertion
Primary Outcome Measure Information:
Title
The success rates of fiberscope-guided NG tube insertion
Description
fiberscope-guided NG tube insertion
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: dysphagia patients who need nasogastric tube feeding Exclusion criteria: Patients who ever had human immunodeficiency virus infection and were not suitable for fiberscope exam without protection sheath
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHI-MAW LIN, MD
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Explore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion
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