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) studied | Aortic valve stenosis |
| Date of first enrollment | 17/10/2025 |
| Target sample size | 30 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Incidence of upper airway obstruction |
|---|---|
| Secondary Outcome | Incidence 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 maximum | Not applicable |
| Gender | Both |
| Include criteria | 1) 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 criteria | 1) 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
| Primary Sponsor | Asai Takashi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Hidetoshi Nagayama |
| Address | 2-1-50,Minamikoshigaya,Koshigaya,Saitama Saitama Japan 343-8555 |
| Telephone | +81-489651111 |
| 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 |
| h-nagayama@dokkyomed.ac.jp | |
| Affiliation | Dokkyo Medical U niversity Saitama Medical Center |