The Feasibility Study of Dual-Section Nasogastric Tube

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649349
• Other study ID #: 110807
• Secondary ID: TW201010751
• Status: Completed
• Phase: Phase 0
• First received: June 29, 2012
• Last updated: July 22, 2012
• Start date: May 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mouth Neoplasms
• Stroke

Intervention

Device:
• two-piece nasogastric tube
one week period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	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	Yes
Secondary	satisfaction of Dual-Section Nasogastric Tube	using Likert scale for overall satisfaction	participants will be followed for the duration of hospital stay, an expected average of 1 weeks	No