HFNC and Hypoxia During Percutaneous Radiofrequency Ablation Under Conscious Sedation: A Randomized Clinical Trial

Study Overview
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Brief Summary
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Background: Propofol based sedated anesthesia was widely used in percutaneous radiofrequency ablation and hypoxia is one of the most frequent adverse events during this procedure. No effective methods have been found to prevent hypoxia so far. The aim of this study was to evaluate whether the incidence of hypoxia was different under high-flow nasal cannula (HFNC) therapy, which can provide heated and humidified oxygen up to 60L/minute. Methods: In a randomized, prospective and double-blind study, 318 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 during surgery. Other adverse events were also recorded.

Detailed Description
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After received the approvement of ethics committee of the Cancer Hospital of the University of Chinese Academy of Sciences (approval number IRB-2022). The study was registered before patient enrollment in Clinicaltrials.Written informed consent was obtained from all participants. The study was performed from Feb 1,2022 to August 31, 2022. 100 adult gastric cancer patients between 18-75 years, ASA physical state I and II, undergoing percutaneous radiofrequency ablation, were enrolled in this study. Preoperative arrangements 3-lead electrocardiogram, pulse oximetry and non-invasive blood pressure were measured for basic monitoring. Local anaesthesia was induced by administering 7 ml of 2% lidocaine before the ablation needle was first inserted into the tumour. Then, 0.15 mg/kg oxycodone (diluted to 1 mg/ml with normal saline; Mundipharma, Vantaa, Finland) was administered to both groups. Rescue opioids were administered when the numerical rating scale (NRS) score was greater than 4 or when the patient had obvious, unwanted body movements. The rescue OXY dose was 0.05 mg/kg with the total dose not to exceed 0.25 mg/kg. Blood pressure was measured every 3 minutes as well as 2 minutes after the drug was administered or at the discretion of the anaesthesiologist. All patients remained in the PACU under monitoring for at least 30 minutes until their Aldrete score was between 9 to 10. Mean blood pressure, heart rate, and respiratory rate were recorded. The effect site concentration of propofol is 1.3 ug/ml at the beginning and adjusted at a stepwise of 0.3 ug/ml to maintain a sedation score between 3-4. The depth of sedation was assessed and recorded every 3 minutes by OAA/S.

Official Title
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High-flow Nasal Cannula Oxygen Therapy and Hypoxia During Percutaneous Radiofrequency Ablation Under Conscious Sedation: A Randomized Clinical Trial

Conditions
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Propofol Syndrome, Hypoxia, Sedation Complication

Intervention / Treatment
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* Device: high-flow oxygen nasal cannula therapy
* Other: nasal cannula oxygen therapy


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Nasal cannula group<br>Heated and humidified oxygen of 6 L/minute was supplied via an HFNC | Other: nasal cannula oxygen therapy<br>* Heated and humidified oxygen of 6L/minute through high-flow nasal cannula (HFNC) therapy machine.<br>|
| Experimental: High-flow nasal cannula (HFNC)<br>Heated and humidified oxygen of 40 L/minute was supplied via an HFNC | Device: high-flow oxygen nasal cannula therapy<br>* Heated and humidified oxygen of 40L/minute through high-flow nasal cannula (HFNC) therapy machine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia | Observe the incidence of hypoxia between the two groups | throughout the procedure |