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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025058
Receipt No. R000028697
Scientific Title Changes of laryngeal airway patency in anesthetized children with supraglottic airway devices
Date of disclosure of the study information 2016/11/29
Last modified on 2018/10/01

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Basic information
Public title Changes of laryngeal airway patency in anesthetized children with supraglottic airway devices
Acronym Laryngeal airway patency in anesthetized children with suplaglottic airway devices
Scientific Title Changes of laryngeal airway patency in anesthetized children with supraglottic airway devices
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuji Kitamura
Organization Chiba University Hospital
Division name Depatment of Anesthesiology
Zip code
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
1st name
Middle name
Last name Shiroh Isono
Organization Chiba Graduate School of Medicine
Division name Anesthesiology
Zip code
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)

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
2016 Year 11 Month 29 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
2016 Year 11 Month 14 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000028697

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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