Explore the Efficiency of Fiberscope-guided Nasogastric T... | NCT03415451

Studies
Explore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion

NCT03415451

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Mar 5, 2019Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Nasogastric Tube Esophagitis

Interventions

Fiberscope-Guided Nasogastric tube insertion

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Jul 30, 2018Actual

Completion Date

Jul 30, 2018Actual

First Submitted Date

Oct 1, 2017

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2019

Last Update Posted Date

Mar 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fiberscope-Guided Nasogastric tube	Experimental	Fiberscope-Guided Nasogastric tube insertion	Device: Fiberscope-Guided Nasogastric tube insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fiberscope-Guided Nasogastric tube insertion	Device	Fiberscope-Guided Nasogastric tube insertion	Fiberscope-Guided Nasogastric tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The success rates of fiberscope-guided NG tube insertion	fiberscope-guided NG tube insertion	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CHI-MAW LIN, MD	National Taiwan University Hospital, Yun-Lin Branch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan