HFNC and Hypoxia/Desaturation During Radiofrequency Ablation Under Moderate Sedation: A Randomized Clinical Trial
Condition: Propofol; Hypoxia; Sedation Complication; Desaturation of Blood
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): high-flow oxygen nasal cannula therapy; nasal cannula oxygen therapy
Intervention type(s): Device; Other
Intervention description(s): Heated and humidified oxygen of 40L/minute through high-flow nasal cannula (HFNC) therapy machine.; Heated and humidified oxygen of 6L/minute through high-flow nasal cannula (HFNC) therapy machine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention