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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013190
Receipt No. 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

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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
Email 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
Email mizuno.k@fcho.jp

Sponsor
Institute Department of Anesthesia, Fukuoka Children's Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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