UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046589 |
|---|---|
| Receipt number | R000053146 |
| Scientific Title | Examination of the effectiveness of the jaw elevation device in airway management during transcatheter aortic valve replacement performed with sedation and local anesthesia. |
| Date of disclosure of the study information | 2022/01/08 |
| Last modified on | 2022/01/08 12:41:32 |
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Basic information
Public title
Examination of the effectiveness of the jaw elevation device in airway management during transcatheter aortic valve replacement performed with sedation and local anesthesia.
Acronym
Examination of the effectiveness of the jaw elevation device in airway management during transcatheter aortic valve replacement performed with sedation and local anesthesia.
Scientific Title
Examination of the effectiveness of the jaw elevation device in airway management during transcatheter aortic valve replacement performed with sedation and local anesthesia.
Scientific Title:Acronym
Examination of the effectiveness of the jaw elevation device in airway management during transcatheter aortic valve replacement performed with sedation and local anesthesia.
Region
| Japan |
Condition
Condition
Valvular disease for indication of transcatheter aortic valve replacement
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Most patients undergoing transcatheter aortic valve implantation (TAVI) are elderly with severe aortic stenosis, and the 30-day mortality rate is significantly lower with sedation /local anesthesia than with general anesthesia management. With sedation and local anesthesia, airway narrowing and obstruction due to intraoperative glossoptosis frequently occur. The Jaw Elevation Device (JED) is a non-invasive device that prevents airway narrowing in medical procedures performed under spontaneous breathing and sedation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subjects were TAVI cases performed by sedation and local anesthesia at our facility. We defined the time when patients entered the operating room and were in the supine position as T0. We defined the time at when dexmedetomidine and propofol were administered and sedation was achieved without movement even with strong pinching as T1. Next, we defined the time when the JED was attached as T2. X-ray images of the head and neck were taken at T0, T1, and T2, and we measured the distance from the soft palate to the posterior pharyngeal wall (AW1) and the distance from the epiglottis to the posterior pharyngeal wall (AW2). We calculated the ratio of AW1 and AW2 in T1 to T0 and the ratio of AW1 and AW2 in T2 to T0, and determined the effect of JED on preventing airway obstruction.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Jaw Elevation Device:JED
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
TAVI cases performed by sedation and local anesthesia at our facility.
Key exclusion criteria
Patients with a history of cervical spondylosis.Patients who refused to participate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisanari |
| Middle name | |
| Last name | Ishii |
Organization
Tenri Hospital
Division name
Department of Anesthesiology
Zip code
632-8552
Address
200 Mishima-cho, Tenri, Nara 632-8552, Japan
TEL
0743-63-5611
hisanari@tenriyorozu.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Mishima |
Organization
Tenri Hospital
Division name
Department of Anesthesiology
Zip code
632-8552
Address
200 Mishima-cho, Tenri, Nara 632-8552, Japan
TEL
0743-63-5611
Homepage URL
hiroki.mishima@ompu.ac.jp
Sponsor or person
Institute
Tenri Hospital
Institute
Department
Personal name
Funding Source
Organization
Tenri Hospital
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
Tenri Hospital
Address
200 Mishima-cho, Tenri, Nara 632-8552, Japan
Tel
0743-63-5611
chiken@tenriyorozu.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
No.1239
Org. issuing International ID_1
Tenri Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | 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
| 2022 | Year | 01 | Month | 08 | Day |
Last modified on
| 2022 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053146
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| Registered date | File name |
| Research case data | |
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