Liver AblationNCT07211763
Comparison of Transcutaneous and Arterial Carbon Dioxide Sampling During Jet Ventilation, a Prospective. Study on Patients Undergoing Percutaneous Liver Tumour Radiofrequency Ablation
An observational study of Liver Ablation and High Frequency Jet Ventilation, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The study aims to compare the readings from two methods of monitoring carbon dioxide levels during jet ventilation when normal end-tidal monitoring is not possible. During jet ventilation it is technically not possible to monitor the levels of carbon dioxide in exhaled air as is the standard in preoperative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Ablation, High Frequency Jet Ventilation
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing percutaneous RF liver ablation under jet ventilation
Who may be able to join
- adult patients undergoing percutaneous RF liver tumour ablation requiring jet ventilation
Who cannot join
- disease or condition. not compatible with jet ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Fredrik Olsen, MD PhD, +463134328169, fredrik.olsen@vgregion.se
About this study
Official title: Transcutaneous Versus Arterial Carbon Dioxide Monitoring During Jet Ventilation
The study aims to compare the readings from two methods of monitoring carbon dioxide levels during jet ventilation when normal end-tidal monitoring is not possible. During jet ventilation it is technically not possible to monitor the levels of carbon dioxide in exhaled air as is the standard in preoperative care. We will compare transcutaneous (through the skin) monitoring to an arterial blood. sample. Both transcutaneous monitoring and arterial monitoring is currently used as the standard for this patient group at our institution. By collecting data prospectively we can evaluate if there. are discrepancies based on monitoring method. All patients will be treated per standard preoperative protocol and only patients consenting to participate will contribute data to the comparison and statistical analysis.
Read the detailed description
During percutaneous radio frequency ablation of liver tumours, jet. ventilation is used to minimise diaphragm movement. By not having conventional ventilation the interventional radiologist have better conditions to perform the treatment and minimising risk damaging adjacent tissue. Jet ventilation does however remove the possibility to monitor end tidal CO2, necessitating alternative monitoring to ensure adequate ventilation. At our institution we use transcutaneous and arterial blood gas monitoring. We aim to collect data on both modalities and compare the values using a "repeat measure Bland-Altmann" analysis.
Study participants will be managed as per normal protocol and the only difference to the non-participators will be their contribution of prospective data for later analysis.
- Conditions
- Liver Ablation, High Frequency Jet Ventilation
- Being tested
- No Interventions
- Keywords
- jet ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No intervention, solely data collection
| Study group | Role | What they receive |
|---|---|---|
| jet_ventilation | Not described Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in CO2 between TcCO2 and PaCO2
Measured: during perioperative management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver AblationStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik Olsen, Sahlgrenska University Hospital
- Investigators
- Fredrik Olsen, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211763
- Sponsor's protocol ID
- LiverJet
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Versus Arterial Carbon Dioxide Monitoring During Jet Ventilation
- ClinicalTrials.gov ID
- NCT07211763
- Acronym / sponsor ID
- LiverJet
- Conditions
- Liver Ablation, High Frequency Jet Ventilation
- Keywords
- jet ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Oct 2025 (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.
The study aims to compare the readings from two methods of monitoring carbon dioxide levels during jet ventilation when normal end-tidal monitoring is not possible. During jet ventilation it is technically not possible to monitor the levels of carbon dioxide in exhaled air as is the standard in preoperative care. We will compare transcutaneous (through the skin) monitoring to an arterial blood. sample. Both transcutaneous monitoring and arterial monitoring is currently used as the standard for this patient group at our institution. By collecting data prospectively we can evaluate if there. are discrepancies based on monitoring method. All patients will be treated per standard preoperative protocol and only patients consenting to participate will contribute data to the comparison and statistical analysis.
Detailed description
During percutaneous radio frequency ablation of liver tumours, jet. ventilation is used to minimise diaphragm movement. By not having conventional ventilation the interventional radiologist have better conditions to perform the treatment and minimising risk damaging adjacent tissue. Jet ventilation does however remove the possibility to monitor end tidal CO2, necessitating alternative monitoring to ensure adequate ventilation. At our institution we use transcutaneous and arterial blood gas monitoring. We aim to collect data on both modalities and compare the values using a "repeat measure Bland-Altmann" analysis.
Study participants will be managed as per normal protocol and the only difference to the non-participators will be their contribution of prospective data for later analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| jet_ventilation | – | Other: No Interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing percutaneous RF liver ablation under jet ventilation
Key inclusion criteria (1 listed)
- adult patients undergoing percutaneous RF liver tumour ablation requiring jet ventilation
Key exclusion criteria (1 listed)
- disease or condition. not compatible with jet ventilation
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 |
|---|---|---|
| No InterventionsNo intervention, solely data collection | Other | jet_ventilation |
Primary outcome
Difference in CO2 between TcCO2 and PaCO2
Time frame: during perioperative management
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
Fredrik Olsen, MD PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Ablation and High Frequency Jet Ventilation, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Oct 2025. 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 Sweden. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Olsen, MD PhD (+46 313428169, fredrik.olsen@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in CO2 between TcCO2 and PaCO2 (time frame: during perioperative management). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2025.