UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes of laryngeal airway patency in anesthetized children with supraglottic airway devices
Title of the study (Brief title)	Laryngeal airway patency in anesthetized children with suplaglottic airway devices
Region	Japan

Condition
Condition	anesthetized children with suplaglottic airway devices
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test an hypothesis that use of sugammadex for reversal of muscle paralysis changes laryngeal airway patency during emergence from general anesthesia in children with suplaglottic airway devices.
Basic objectives2	Others
Basic objectives -Others	To explore whether mechanical parameters such as respiratory sound and respiratory resistance reflect changes of laryngeal airway patency.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	vocal cord angle
Key secondary outcomes	respiratory mechanics parameters such as respiratory sound and respiratory resistance

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	1 years-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients who will be anesthetized for inguinal hernia surgery and cryptorchidism surgery 2)Patients whom supraglottic airway devices will be used for 3)Patients who is categorized as American Society of Anesthesia-Physical status 1-3 4)Patients whose weight is over 10 kg at the surgery time 5)Patients whose age is under 6 years old at the surgery time 6)No regard to sex 7)Patients whose parents are given informed consent about this research
Key exclusion criteria	1)Patients who are at the risk of aspiration 2)Patients whose surgery will be laparoscopic 3)Patients who is under oxypathy 4)Patients who have coagulation abnormality 5)Patients whom supraglottic airway devices don't fit 6)Patients who are under tubal feeding 7)Patients who have the history of larynx disease 8)Patients who take anti-convulsion drugs 9)Patients who have the history of being intubated within one month 10)Patients who are thought to be inadequate by researchers
Target sample size	20

Research contact person
Name of lead principal investigator	Yuji Kitamura
Organization	Chiba University Hospital
Division name	Depatment of Anesthesiology
Address	inohana1-8-1,Chuou ku ,Chiba City,Chiba Ken
TEL	043-222-7171
Email	yuji.kitamura@chiba-u.jp

Public contact
Name of contact person	Shiroh Isono
Organization	Chiba Graduate School of Medicine
Division name	Anesthesiology
Address	Inohana 1-8-1,Chuou ku,Chiba City,Chiba ken
TEL	043-222-7171
Homepage URL
Email	shirohisono@yahoo.co.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization	Other
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	2016 Year 11 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 14 Day
Anticipated trial start date	2016 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry	2018 Year 07 Month 27 Day
Date trial data considered complete	2018 Year 09 Month 03 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We will endoscopically observe and measure the vocal cord angle of the anesthetized children through a supraglottic airway device(SAD). Primary outcome measure is the change of the vocal cord angle before and after reversal of muscle paralysis by sugammadex and the secondary outcome is characteristics of respiratory sounds and other respiratory mechanics parameters such as tidal volume. Study protocol 1) A written informed consent is obtained from each of the parent of the child who is scheduled to have a minor surgery in our hospital. Premedication will be used if needed. 2) At operation room, the child will be anesthetized by inhalational anesthetics such as sevoflurane and nitrous oxide and a venous line is secured after appropriate cardiorespiratory monitor such as pulse oximetry is attached to the child. After placement of a SAD, general anesthesia is maintained by appropriate dose of sevoflurane, fentanyl, remifentanil and rocuronium. Mechanical ventilation will be started for maintaining optimal oxygenation and ventilation during the surgery while measuring the respiratory parameters. An endoscope will be inserted through the SAD to measure the vocal cord angle. The respiratory parameters and endoscopic images were displayed on the screen and stored in a computer for later analysis. The measurement will be ceased when the SAD is removed after completion of the surgery.

Management information
Registered date	2016 Year 11 Month 29 Day
Last modified on	2018 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028697