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The Feasibility Study of Dual-Section Nasogastric Tube

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tsung Ju Wu, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT01649349
First received: June 29, 2012
Last updated: July 22, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Stroke
Mouth Neoplasms
 Device: two-piece nasogastric tube
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Feasibility Study of Dual-Section Nasogastric Tube in Dysphagia Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Oral Cancer
U.S. FDA Resources

Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks ] [ Designated as safety issue: No ]
    using Likert scale for overall satisfaction


Enrollment: 10
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: two-piece nasogastric tube
    one week period
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Tsung Ju Wu, M.D., Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01649349     History of Changes
Other Study ID Numbers: 110807, TW201010751
Study First Received: June 29, 2012
Last Updated: July 22, 2012
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Mouth Neoplasms
Stroke
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013