UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030050 |
|---|---|
| Receipt number | R000034295 |
| Scientific Title | The Parker Flex-Tip tube for tracheal intubation with the Airway Scope: A comparison with standard tracheal tube |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2022/03/21 14:47:13 |
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Basic information
Public title
The Parker Flex-Tip tube for tracheal intubation with the Airway Scope: A comparison with standard tracheal tube
Acronym
The Parker Flex-Tip tube for tracheal intubation with the Airway Scope
Scientific Title
The Parker Flex-Tip tube for tracheal intubation with the Airway Scope: A comparison with standard tracheal tube
Scientific Title:Acronym
The Parker Flex-Tip tube for tracheal intubation with the Airway Scope
Region
| Japan |
Condition
Condition
Patients who undergo surgery under general anesthesia with tracheal intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of the Parker Flex-Tip tube on ease of tracheal intubation with the Airway Scope.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of impact of the tube on larynx
Key secondary outcomes
intubation time, number of tracheal intubation
Incidence of sore throat and hoarseness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
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 of the Parker Flex-Tip tube during tracheal intubation procedure
Interventions/Control_2
use of a tracheal tube during tracheal intubation procedure
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 yr or older, with ASA physical status I-III, scheduled to receive general anesthesia and tracheal intubation.
Key exclusion criteria
Patients with pharyngeal pathology, at risk of pulmonary aspiration of gastric contents,
or predicted difficult mask ventilation
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Aoyama |
Organization
Kitakyushu General Hospital
Division name
Department of Anesthesia
Zip code
802-8517
Address
1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu
TEL
093-921-0560
kazuyoshi.aoyama@kitakyu-hp.or.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Aoyama |
Organization
Kitakyushu General Hospital
Division name
Department of Anesthesia
Zip code
Kazuyoshi
Address
1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu
TEL
093-921-0560
Homepage URL
kazuyoshi.aoyama@kitakyu-hp.or.jp
Sponsor or person
Institute
Kitakyushu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitakyushu General Hospital
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
Ethics committee of Kitakyushu General Hospital
Address
1-1 Higashijono-machi, Kokurakita- ku, Kitakyushu
Tel
093-921-0560
yoshifumi.nakayama@kitakyu-hp.or.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
北九州総合病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
40
Results
During intubation with the AWS, rate of difficulty in tube advancement was 5 and 40% in Parker tube and standard tube groups, respectively.
Results date posted
| 2022 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
adult patients who received general anesthsesia
Participant flow
no problem
Adverse events
none
Outcome measures
rate of intubation difficulty
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034295
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
