Examination of the effectiveness of the jaw elevation device in airway management during transcatheter aortic valve replacement performed with sedation and local anesthesia.

Examination of the effectiveness of the jaw elevation device in airway management during transcatheter aortic valve replacement performed with sedation and local anesthesia. - Examination of the effectiveness of the jaw elevation device in airway management during transcatheter aortic valve replacement performed with sedation and local anesthesia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046589

Enrollment

Registered

2022-01-08

Start date

2021-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular disease for indication of transcatheter aortic valve replacement

Interventions

Jaw Elevation Device:JED

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: TAVI cases performed by sedation and local anesthesia at our facility.

Exclusion criteria

Exclusion criteria: Patients with a history of cervical spondylosis.Patients who refused to participate.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactHiroki Mishima

Tenri Hospital Department of Anesthesiology

hiroki.mishima@ompu.ac.jp0743-63-5611

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026