UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025058 |
|---|---|
| Receipt number | 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 10:22:32 |
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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
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
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028697
