UMIN-CTR Clinical Trial

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