HFNC and Hypoxia/Desaturation During Radiofrequency Ablation Under Moderate Sedation: A Randomized Clinical Trial

High-flow Nasal Cannula Oxygen Therapy and Hypoxia/Desaturation During Percutaneous Radiofrequency Ablation Under Moderate Sedation: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Propofol; Sedation Complication; Desaturation of Blood
• Intervention / Treatment: Other: nasal cannula oxygen therapy; Device: high-flow oxygen nasal cannula therapy

Detailed Description

After received the approvement of ethics committee of the Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital, approval number IRB-2022-262). The study was registered before patient enrollment in Clinicaltrials.Written informed consent was obtained from all participants. 100 adult patients between 18-75 years, ASA physical state I to III, 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 MOAA/S.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxia	Observe the incidence of hypoxia/desaturation between the two groups	Throughout the procedure

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Study Chair: Ji Zhu, Ph.D, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): August 17, 2023
• Study Completion (Actual): August 17, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: IRB-2022-262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No