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JAPANESE
JRCT ID: jRCT1032250469

Registered date:30/10/2025

Incidence of Airway-Related Complications in Sedation-Assisted Transcatheter Aortic Valve Implantation Using High-Flow Oxygen Therapy

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAortic valve stenosis
Date of first enrollment17/10/2025
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)

Outcome(s)

Primary OutcomeIncidence of upper airway obstruction
Secondary OutcomeIncidence of hypoxemia Names and doses of sedatives and opioid analgesics Frequency of temporary interruptions in surgery due to tracheal intubation, etc.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1) Patients undergoing transcatheter aortic valve implantation under sedation 2) Patients aged 18 years or older at the time of surgery 3) Patients with an American Society of Anesthesiologists (ASA) physical status classification of Class 3 Class 3: Patients with severe systemic disease (e.g., poorly controlled hypertension or diabetes, chronic obstructive pulmonary disease, severe obesity, cardiac dysfunction, end-stage renal failure) 4) Patients for whom consent for participation in this study can be obtained from the patient or a legal representative
Exclude criteria1) Patients undergoing emergency surgery 2) Patients who may be pregnant 3) Patients with a body mass index (BMI) of 35 or higher 4) Patients with a history of upper airway surgery

Related Information

Contact

Public contact
Name Hidetoshi Nagayama
Address 2-1-50,Minamikoshigaya,Koshigaya,Saitama Saitama Japan 343-8555
Telephone +81-489651111
E-mail h-nagayama@dokkyomed.ac.jp
Affiliation Dokkyo Medical U niversity Saitama Medical Center
Scientific contact
Name Takashi Asai
Address 2-1-50,Minamikoshigaya,Koshigaya,Saitama Saitama Japan 343-8555
Telephone +81-489651111
E-mail h-nagayama@dokkyomed.ac.jp
Affiliation Dokkyo Medical U niversity Saitama Medical Center