JRCT ID: jRCT1032250187
Registered date:26/06/2025
Comparison of Hemodynamic Changes between High-Flow Nasal Oxygen Therapy and Face Mask Ventilation
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Patients undergoing surgery under general anesthesia |
| Date of first enrollment | 26/06/2025 |
| Target sample size | 60 |
| Countries of recruitment | nonen,Japan |
| Study type | Interventional |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Incidence of hypotension (defined as a mean arterial pressure < 65 mmHg at the point of greatest blood pressure decrease) |
|---|---|
| Secondary Outcome | Total dose of vasopressors administered during anesthesia induction Incidence of hypoxemia (defined as a lowest oxygen saturation < 95%) |
Key inclusion & exclusion criteria
| Age minimum | >= 70age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients scheduled to undergo surgery under general anesthesia Patients scheduled to receive remimazolam as a sedative agent for anesthesia induction Patients aged 70 years or older at the time of consent acquisition Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class 1 to 3 Class 1 A normal healthy patient without organic, physiological, biochemical, or psychiatric disturbances. The surgical condition is localized and does not cause systemic disturbance. Class 2 A patient with mild to moderate systemic disease, either due to the condition requiring surgery or other pathophysiological causes. Class 3 A patient with severe systemic disease, regardless of the underlying cause or whether the degree of dysfunction can be precisely determined. Patients who have provided informed consent to participate in the study |
| Exclude criteria | 1.Patients undergoing emergency surgery 2.Patients undergoing cardiac surgery 3.Patients who may be pregnant 4.Patients with a predicted difficult airway or anticipated difficult intubation 5.Patients with a body mass index (BMI) of 35 or higher 6.Patients considered to be at high risk of aspiration 7.Patients with conditions in which carbon dioxide retention is undesirable (e.g., pulmonary hypertension, right heart failure) 8.Patients with a history of ischemic heart disease or heart failure 9.Patients receiving dialysis |
Related Information
| Primary Sponsor | Asai Takashi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Ryosuke Osawa |
| Address | 2-1-50,Minamikoshigaya,Koshigaya,Saitama Saitama Japan 343-8555 |
| Telephone | +81-48-965-1111 |
| r-oosawa@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 | +81-48-965-1111 |
| r-oosawa@dokkyomed.ac.jp | |
| Affiliation | Dokkyo Medical U niversity Saitama Medical Center |