UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005023 |
|---|---|
| Receipt number | R000005973 |
| Scientific Title | Real time ultrasound guided percutaneous dilatational tracheostomy: a feasibility study |
| Date of disclosure of the study information | 2011/02/04 |
| Last modified on | 2011/02/04 11:15:04 |
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Basic information
Public title
Real time ultrasound guided percutaneous dilatational tracheostomy: a feasibility study
Acronym
Ultrasound guided percutaneous tracheostomy
Scientific Title
Real time ultrasound guided percutaneous dilatational tracheostomy: a feasibility study
Scientific Title:Acronym
Ultrasound guided percutaneous tracheostomy
Region
| North America |
Condition
Condition
Acute brain injury, requiring tracheostomy
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility of ultrasound guided tracheal puncture during percutaneous tracheostomy
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Placement of guidewire between 1st and 5th tracheal rings.
2. Successful completion of tracheostomy without complication
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Real-time ultrasound guided tracheal puncture during percutaneous tracheostomy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Treating physician has designated the patient to undergo percutaneous tracheostomy
Key exclusion criteria
Clinical contraindication for percutaneous tracheostomy in the opinion of the treating physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Venkatakrishna Rajajee |
Organization
University of Michigan
Division name
Department of Neurosurgery
Zip code
Address
Ann Arbor. MI
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Venkatakrishna Rajajee |
Organization
University of Michigan
Division name
Neurosurgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University of Michigan Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 04 | Day |
Last modified on
| 2011 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005973
