Hypoxia Clinical Trial
Official title:
High-flow Nasal Cannula Oxygen Therapy and Hypoxia/Desaturation During Percutaneous Radiofrequency Ablation Under Moderate Sedation: A Randomized Clinical Trial
Verified date | February 2024 |
Source | Zhejiang Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Propofol based sedated anesthesia was widely used in percutaneous radiofrequency ablation and hypoxia/desaturation is one of the most frequent adverse events during this procedure. No effective methods have been found to prevent hypoxia/desaturation so far. The aim of this study was to evaluate whether the incidence of hypoxia/desaturation was different between the high-flow nasal cannula (HFNC) therapy group (which can provide heated and humidified oxygen up to 60L/minute.) and the nasal cannula group. Methods: In a randomized, prospective and double-blind study,100 patients undergo percutaneous radiofrequency ablation based on propofol sedation were assigned into two groups: the nasal cannula group (O2 [6 L/minute] was supplied via an HFNC) and the HFNC group (O2 [40 L/minute] was supplied via an HFNC). The primary outcome is the incidence of hypoxia/desaturation during surgery. Other adverse events were also recorded.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 17, 2023 |
Est. primary completion date | August 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 18< age < 75 years; - ASA physical state I and II; .Undergoing percutaneous radiofrequency ablation. Exclusion Criteria: - Age < 18 years or older than 75 years; - America Society of Anesthesiologists (ASA) class >III; - Allergic to anesthetic solutions; - Tendency for nose bleeding or coagulation disorders; - Local infection (eg. mouth, nose, or throat infection); - Heart disease like congestive heart failure, severe aortic stenosis or mitral stenosis, cardiac surgery involving thoracotomy (eg, coronary artery bypass graft or valve replacement surgery) in the last 6 months; acute myocardial infarction in the last 6 months; acute arrhythmia (including tachycardia and bradycardia) with hemodynamic instability; - Diagnosed chronic obstructive pulmonary disease (COPD) or other current acute or chronic lung diseases requiring supplemental chronic or intermittent oxygen therapy; - Increased intracranial pressure; - Fever, defined as core body temperature >37.5 C; - Severe anemia (30g/L< hemoglobin <6g/L); - Emergency surgery; - Patients refuse to participate; |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Cancer hospital | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypoxia | Observe the incidence of hypoxia/desaturation between the two groups | Throughout the procedure |
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