PropofolNCT05212064
HFNC and Hypoxia/Desaturation During Radiofrequency Ablation Under Moderate Sedation: A Randomized Clinical Trial
A study testing high-flow oxygen nasal cannula therapy and nasal cannula oxygen therapy in people with Propofol and Hypoxia, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Propofol, Hypoxia, Sedation Complication
- What is being tested?
- high-flow oxygen nasal cannula therapy and nasal cannula oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 17 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18< age < 75 years;
- ASA physical state I and II; .Undergoing percutaneous radiofrequency ablation.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Propofol, Hypoxia, Sedation Complication, Desaturation of Blood
- Being tested
- high-flow oxygen nasal cannula therapy, nasal cannula oxygen therapy
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flow oxygen nasal cannula therapyDevice
Heated and humidified oxygen of 40L/minute through high-flow nasal cannula (HFNC) therapy machine.
nasal cannula oxygen therapyOther
Heated and humidified oxygen of 6L/minute through high-flow nasal cannula (HFNC) therapy machine.
| Study group | Role | What they receive |
|---|---|---|
| Nasal cannula group | Sham comparator | Heated and humidified oxygen of 6 L/minute was supplied via an HFNC Receives: Other: nasal cannula oxygen therapy |
| High-flow nasal cannula (HFNC) | Experimental | Heated and humidified oxygen of 40 L/minute was supplied via an HFNC Receives: Device: high-flow oxygen nasal cannula therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia
Observe the incidence of hypoxia/desaturation between the two groups
Measured: Throughout the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2022
- Primary completion17 Aug 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PropofolStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jiangling, Zhejiang Cancer Hospital
- Investigators
- Ji Zhu, Ph.D, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212064
- Sponsor's protocol ID
- IRB-2022-262
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40771463
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygen Therapy and Hypoxia/Desaturation During Percutaneous Radiofrequency Ablation Under Moderate Sedation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05212064
- Acronym / sponsor ID
- IRB-2022-262
- Conditions
- Propofol, Hypoxia, Sedation Complication, Desaturation of Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal cannula group | Sham comparator | Other: nasal cannula oxygen therapyHeated and humidified oxygen of 6 L/minute was supplied via an HFNC |
| High-flow nasal cannula (HFNC) | Experimental | Device: high-flow oxygen nasal cannula therapyHeated and humidified oxygen of 40 L/minute was supplied via an HFNC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18< age < 75 years;
- ASA physical state I and II; .Undergoing percutaneous radiofrequency ablation.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-flow oxygen nasal cannula therapyHeated and humidified oxygen of 40L/minute through high-flow nasal cannula (HFNC) therapy machine. | Device | High-flow nasal cannula (HFNC) |
| nasal cannula oxygen therapyHeated and humidified oxygen of 6L/minute through high-flow nasal cannula (HFNC) therapy machine. | Other | Nasal cannula group |
Primary outcome
Hypoxia
Time frame: Throughout the procedure
Observe the incidence of hypoxia/desaturation between the two groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Derived from this study: PubMed 40771463Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Zhu, Ph.D study chair
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-flow oxygen nasal cannula therapy and nasal cannula oxygen therapy in people with Propofol and Hypoxia, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia (time frame: Throughout the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05212064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.