UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the MED-P STRIP: a pediatric emergency scale tape
Title of the study (Brief title)	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	Keiichiro Mizuno
Organization	Fukuoka Children's Hospital
Division name	Department of Anesthesia
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	Keiichiro Mizuno
Organization	Fukuoka Children's Hospital
Division name	Department of Anesthesia
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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