UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032360 |
|---|---|
| Receipt number | R000028907 |
| Scientific Title | Influence of supporting method of tracheal tube during general anesthesia on postoperative sore throat |
| Date of disclosure of the study information | 2018/04/24 |
| Last modified on | 2023/11/08 16:38:17 |
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Basic information
Public title
Influence of supporting method of tracheal tube during general anesthesia on postoperative sore throat
Acronym
Influence of supporting method of tracheal tube during general anesthesia on postoperative sore throat
Scientific Title
Influence of supporting method of tracheal tube during general anesthesia on postoperative sore throat
Scientific Title:Acronym
Influence of supporting method of tracheal tube during general anesthesia on postoperative sore throat
Region
| Japan |
Condition
Condition
Patients under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and examine whether the occurrence frequency of postoperative sore throat pain differs depending on the support method of two tracheal tubes for patients who underwent general anesthesia requiring tracheal intubation at Tsukuba University Hospital. It is a comparison of the tracheal tube support method that is usually done clinically and normally.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
On the day of surgery (2 hours after surgery): Yahara surveyed the presence or absence of sore throat pain and VAS and sore throat score after surgery
Next day after surgery (24 hours after surgery) APS examines the presence or absence of postoperative sore throat and VAS and sore throat score
VAS (0: no postoperative sore throat or hoarseness, 100: maximum imaginable postoperative sore throat or hoarseness)
The frequency and severity of postoperative sore throat pain between the two groups are compared using Chi-square test and Mann-Whitney test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Natural group: Connect the coiled tube using Godzilla while maintaining the natural shape of the tracheal tube.
Interventions/Control_2
Curved group: Connected to breathing circuit by towing in the plane direction to add curvature of product and curvature to right 90 degrees direction. The force applying curvature is the upper limit force that the lumen of the tracheal tube does not deform from the normal circle.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subject is scheduled surgical patient for adult male and female (20 years old to 85 years old).
Key exclusion criteria
Smoker, more than 180 minutes, indwelling nasogastric tube, insertion of pharyngeal probes, tracheal aspiration, cases where intubation failed in one trial, patients requiring head and neck surgery, sputum
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Musashi Yahagi |
Organization
University of Tsukuba Hospital
Division name
Department of Anesthesia
Zip code
Address
Osaka Suita Aoyamadai 3-32-7
TEL
08033348696
musasum0710@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Musashi Yahagi |
Organization
University of Tsukuba Hospital
Division name
Department of Anesthesia
Zip code
Address
Ibaraki Tsukuba Tennodai 2-1-1
TEL
029-853-3900
Homepage URL
musasum0710@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba 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
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
| 2018 | Year | 04 | Month | 24 | 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 | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028907
