The Feasibility Study of Dual-Section Nasogastric Tube

July 22, 2012 updated by: Tsung Ju Wu, Changhua Christian Hospital

The Feasibility Study of Dual-Section Nasogastric Tube in Dysphagia Patients

The purpose of this studyis to assess the feasibility and safety of novel designed two-piece nasogastric tube.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks
monitor the adverse events like pressure sore, numbers of self-extubation, dislocation of tube, or other unpredictable events.
participants will be followed for the duration of hospital stay, an expected average of 1 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction of Dual-Section Nasogastric Tube
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks
using Likert scale for overall satisfaction
participants will be followed for the duration of hospital stay, an expected average of 1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 29, 2012

First Submitted That Met QC Criteria

July 22, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

July 25, 2012

Last Update Submitted That Met QC Criteria

July 22, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110807
  • TW201010751 (Registry Identifier: DUAL-SECTION NASOGASTRIC TUBE)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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