UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013190 |
|---|---|
| Receipt number | R000015375 |
| Scientific Title | Evaluation of the MED-P STRIP: a pediatric emergency scale tape |
| Date of disclosure of the study information | 2014/02/18 |
| Last modified on | 2016/11/09 10:09:42 |
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Basic information
Public title
Evaluation of the MED-P STRIP: a pediatric emergency scale tape
Acronym
Evaluation of a pediatric emergency scale tape
Scientific Title
Evaluation of the MED-P STRIP: a pediatric emergency scale tape
Scientific Title:Acronym
Evaluation of a pediatric emergency scale tape
Region
| Japan |
Condition
Condition
Children under 18 years of age who is scheduled for surgery under general anesthesia with tracheal intubation or laryngeal mask airway
Classification by specialty
| Pediatrics | Anesthesiology | Emergency medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of a pediatric emergency scale tape; the MED-P STRIP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Select the size of tracheal tube or laryngeal mask airway using the MED-P STRIP. The fitting of the device is evaluated with ventilation and airway leackage.
Key secondary outcomes
Evaluate the weight generated by the MED-P STRIP with the actual weight.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age between one months and 18 years of age capable of having the measurements performed.
2. Parent or legal guardian is willing and able to provide written permission.
Key exclusion criteria
1. Unwilling to participate in the study procedures.
2. Known or apparent limb deformities.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Mizuno |
Organization
Fukuoka Children's Hospital
Division name
Department of Anesthesia
Zip code
Address
5-1-1 Kashii-Teriha, Higashi-ku, Fukuoka, 813-0017, Fukuoka, Japan
TEL
092-682-7000
mizuno.k@fcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichiro Mizuno |
Organization
Fukuoka Children's Hospital
Division name
Department of Anesthesia
Zip code
Address
5-1-1 Kashii-Teriha, Higashi-ku, Fukuoka, 813-0017, Fukuoka, Japan
TEL
092-682-7000
Homepage URL
mizuno.k@fcho.jp
Sponsor or person
Institute
Department of Anesthesia, Fukuoka Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 02 | Month | 18 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
The size of tracheal tube or laryngeal mask airway is selected and patient body weight is estimated with MED-P STRIP during induction of general anestheia. Attending anethesiologist evaluates the fitting of the device by ventilation and airway leak. If ventilation is not effective or leak is too large, airway device is exchanged with different size upon decision of the attending anesthesiologist.
Management information
Registered date
| 2014 | Year | 02 | Month | 18 | Day |
Last modified on
| 2016 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015375
