UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042224 |
|---|---|
| Receipt number | R000048197 |
| Scientific Title | An examination of the usefulness of self-made work hoods for the preventing infection during tracheal intubation |
| Date of disclosure of the study information | 2020/10/23 |
| Last modified on | 2023/05/19 11:53:51 |
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Basic information
Public title
An examination of the usefulness of self-made work hoods for the preventing infection during tracheal intubation
Acronym
An examination of the usefulness of self-made work hoods for the preventing infection during tracheal intubation
Scientific Title
An examination of the usefulness of self-made work hoods for the preventing infection during tracheal intubation
Scientific Title:Acronym
An examination of the usefulness of self-made work hoods for the preventing infection during tracheal intubation
Region
| Japan |
Condition
Condition
Intubation training manikin
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the operability and visibility during tracheal intubation between the acrylic box and a work hood made by ourself for the purpose of improving operability.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operability of laryngoscopy
Key secondary outcomes
time for intubation, operability of mask ventilation, visibility of a patient, Cormack-Lehane grade, POGO score, operability of tube manipulation, total score, ease of assistance of nurse during intubation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Acrylbox
Interventions/Control_2
self-made work food
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
JSA Board Certified Anesthesiologist or Fellow of JSA
Nurse working in the operating room
Key exclusion criteria
Those who the principal investigator deems inappropriate as a subject
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Shinshu University School of Medicine
Division name
Department of anesthesiology and resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263372670
ysugiyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Shinshu University School of medicine
Division name
Department of anesthesiology and resuscitology
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263372670
Homepage URL
ysugiyama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee for medical ethics of Shinshu University school of medicine
Address
3-1-1, Asahi, Matsumoto, Nagano
Tel
0263372572
mdrinri@shinshu-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
http://www.sshinko.com/magazine/?p=2515
Publication of results
Published
Result
URL related to results and publications
http://www.sshinko.com/magazine/?p=2515
Number of participants that the trial has enrolled
30
Results
A self made work hood and a transparent acrylic box were analyzed. Each of them was put on a mannequin for intubation training, and the time required for tracheal intubation was measured. The primary endpoint was tracheal intubation time . In a study of anesthesiologists, there was no significant difference in tracheal intubation time between the AB and SH groups. In a study of nurses, the tracheal intubation time was significantly shorter in the SH group than in the AB group.
Results date posted
| 2023 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifteen anesthesiologists and 15 nurses.
Participant flow
Fifteen anesthesiologists and 15 nurses.
Adverse events
none
Outcome measures
A self-made work hood (SH) and a transparent acrylic box (AB) were analyzed. Each of them was put on a mannequin for intubation training, and the time required for tracheal intubation was measured. The primary endpoint was tracheal intubation time(the time from removing the mask placed on the mannequin to confirming chest elevation by manual ventilation after tracheal intubation). In a study of anesthesiologists, there was no significant difference in tracheal intubation time between the AB and SH groups. In a study of nurses, the tracheal intubation time was significantly shorter in the SH group than in the AB group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048197
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