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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046589
Receipt No. 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

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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
Email 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
Email hiroki.mishima@ompu.ac.jp

Sponsor
Institute Tenri Hospital
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053146

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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