UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029068 |
|---|---|
| Receipt number | R000033233 |
| Scientific Title | A comparison of Parker flex-tip tube and a standard tube for pediatric intubation with the Airwayscope |
| Date of disclosure of the study information | 2017/09/25 |
| Last modified on | 2020/10/13 09:57:38 |
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Basic information
Public title
A comparison of Parker flex-tip tube and a standard tube for pediatric intubation with the Airwayscope
Acronym
Pediatric Intubation with the AWS
Scientific Title
A comparison of Parker flex-tip tube and a standard tube for pediatric intubation with the Airwayscope
Scientific Title:Acronym
Pediatric Intubation with the AWS
Region
| Japan |
Condition
Condition
Pediatric patients planned to tracheal intubation
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In pediatric patients, we compare the ease of intubation tube when intubating using the Airwayscope, which is a type of video laryngoscope.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seconds from checking glottis with the Airwayscope to intubation
Key secondary outcomes
Seconds until airway scope can be removed
Success rate of tracheal intubation
Difficulty in passing through the glottis(Evaluated by visual analogue scale)
Difficulty in passing through cricoid cartilage(Evaluated by visual analogue scale)
Ease of deciding insertion position(Evaluated by visual analogue scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use a Parker tube with a slightly bent tip at the time of tracheal intubation with the Airwayscope.
Interventions/Control_2
Use a marine clot tube used conventionally at the time of tracheal intubation with the Airwayscope.
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
| Not applicable |
Age-upper limit
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who are scheduled surgery or examination under general anesthesia at Shimane University hospital.
2)Patients who are scheduled to perform tracheal intubation at the surgery or examination.
3)Patients who weigh less than 8 kg at the
registration.
4)Patients who are under 2 years old at the registration.
5)Written consent has been obtained by the parents concerning research participation.
Key exclusion criteria
1)Patients who are expected to have difficulty in tracheal intubation.
2)Patients who are expected to have difficulty in mask ventilation.
3)Emergency surgery patients
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Nikai |
Organization
Shimane University Hospital
Division name
Department of intensive care unit
Zip code
693-8501
Address
89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
TEL
0853-20-2295
tetsunatsu2000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Nikai |
Organization
Shimane University Hospital
Division name
Department of intensive care unit
Zip code
693-8501
Address
89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
TEL
0853-20-2295
Homepage URL
tetsunatsu2000@yahoo.co.jp
Sponsor or person
Institute
Shimane University, faculty of medicine, department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Shimane University, faculty of medicine, department of anesthesiology
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
Institutional review boards at Faculty of Medicine, Shimane University
Address
89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
Tel
0853-20-2259
kenkyu@med.shimane-u.ac.jp
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
島根大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 25 | 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
20
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
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 19 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033233
