NCT01649349

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1 stroke

Timeline
Completed

Started May 2012

Shorter than P25 for early_phase_1 stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

June 29, 2012

Last Update Submit

July 22, 2012

Conditions

StrokeMouth Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • satisfaction of Dual-Section Nasogastric Tube

    participants will be followed for the duration of hospital stay, an expected average of 1 weeks

Interventions

two-piece nasogastric tubeDEVICE

one week period

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dysphagia
  • mouth neoplasms
  • stroke
  • already use conventional nasogastric tube for at least 2 weeks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeMouth Neoplasms

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 25, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 25, 2012

Record last verified: 2012-07