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

NCT05212064 | Completed

• 1 other identifier: IRB-2022-262
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Propofol; Hypoxia; Sedation Complication; Desaturation of Blood

Outcome Measures

Primary Outcomes (1)

• Hypoxia

  Observe the incidence of hypoxia/desaturation between the two groups

  Throughout the procedure

Study Arms (2)

Nasal cannula group

SHAM COMPARATOR

Heated and humidified oxygen of 6 L/minute was supplied via an HFNC

Other: nasal cannula oxygen therapy

High-flow nasal cannula (HFNC)

EXPERIMENTAL

Heated and humidified oxygen of 40 L/minute was supplied via an HFNC

Device: high-flow oxygen nasal cannula therapy

Interventions

high-flow oxygen nasal cannula therapy DEVICE

Heated and humidified oxygen of 40L/minute through high-flow nasal cannula (HFNC) therapy machine.

High-flow nasal cannula (HFNC)

nasal cannula oxygen therapy OTHER

Heated and humidified oxygen of 6L/minute through high-flow nasal cannula (HFNC) therapy machine.

Nasal cannula group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< age \< 75 years;
• ASA physical state I and II; .Undergoing percutaneous radiofrequency ablation.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Wang J, Wu Q, Ding Z, Zhang W, Xie K, Mao X, Fang X. High-flow nasal cannula oxygenation reduces desaturation during percutaneous radiofrequency ablation under moderate sedation. Front Med (Lausanne). 2025 Jul 23;12:1517819. doi: 10.3389/fmed.2025.1517819. eCollection 2025.

  PMID: 40771463 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ji Zhu, Ph.D

  Zhejiang Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Resident

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 27, 2022
• Study Start: January 1, 2022
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

CN (1)