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The Feasibility Study of Dual-Section Nasogastric Tube

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ClinicalTrials.gov Identifier: NCT01649349
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : July 25, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this studyis to assess the feasibility and safety of novel designed two-piece nasogastric tube.

Condition or disease Intervention/treatment Phase
Stroke Mouth Neoplasms Device: two-piece nasogastric tube Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Feasibility Study of Dual-Section Nasogastric Tube in Dysphagia Patients
Study Start Date : May 2012
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: two-piece nasogastric tube
    one week period

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
More Information

Responsible Party: Tsung Ju Wu, M.D., Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01649349     History of Changes
Other Study ID Numbers: 110807
TW201010751 ( Registry Identifier: DUAL-SECTION NASOGASTRIC TUBE )
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases