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When using HFJV in liver tumour ablation procedures for optimizing surgical conditions, an ETT size 9 is routinely being used in our department.

In this arm an endotracheal tube of size 8 will be used. This is one size smaller than is routine when HFJV is being used for liver tumour ablation procedures in our department. Worth to note is that an endotracheal tube of size 8 is routine in all other surgical procedures, in men, during general anaesthesia.

Compare the levels of carbon dioxide and if it is related to ETT size when using size 9 (routine) or size 8 (intervention).

Entotracheal tube size

Klara Bergmark, MD

High Frequency Jet Ventilation (HFJV) can be used in liver tumour ablation to minimise breathing related movements. The jet cannula is placed freely inside an endotracheal tube (ETT) and the outflow of air is passive, moving out in the interspace between the jet cannula and the inner walls of the ETT.

This study aims to investigate whether the tube size can influence the washout of carbon dioxide using two different sizes of ETT's.

The aim of the present prospective randomised study is to compare differences in levels of carbon dioxide between two different endotracheal tube-sizes.

Background: High Frequency Jet Ventilation (HFJV) has become an important technique for ventilation during stereotactic near-diaphragm ablation to minimise breathing related movements. Thus, avoiding risks associated to movements and subsequent dislocation of the target tumour. HFJV is being increasingly used during CT-guided, percutaneous liver tumour ablation. As shown previously, breathing related movements in upper abdominal organs, are decreased significantly when compared to conventional ventilation. When HFJV is being used in the setting for tumour ablation the jet cannula is inserted into an ordinary endotracheal tube (ETT). The HFJV catheter is placed in the ETT and is during jet ventilation lying freely within the tube. Right placement is confirmed by a harmonic curve on the screen of the jet ventilator. It is of great importance that the ETT is not obstructed as this type of ventilation is dependent on passive outflow of expired air, through the tube, passing from the lungs around the catheter within the tube into the surrounding air. If the lumen around the catheter within the ETT is becoming too small, there is a risk for intrinsic PEEP built up, and subsequent risk for barotrauma, pneumothorax. The space between the catheter and the inner lumen of the ETT also governs the exhalation of gas, the passage of expired gas containing CO2 from the lung. A small inner diameter of the ETT may thus likewise increase the risk for a raise in arterial carbon dioxide. To minimise these risks, an ETT one size larger than usual can be used to lower the risk for pressure increase and improve gas exchange. One should consider the risks, even though very low, of mechanical injury in the airway when larger ETT's are being used. Previous studies on arterial blood gas in liver tumour was performed using a ETT one size larger (size 9 in men). Tadié et al showed that laryngeal injury was related to the length of intubation, the non-use of muscle relaxant drugs and the height/ETT diameter ratio. This was a study made in an ICU and all patients were intubated \>24 hrs and therefore not fully applicable to the OR-setting. Jaensson et al describe a significant lower risk for post operative sore throat (POST) using a smaller ETT size in women during elective surgery. Myles et al describe women being 1.5 times more likely to report having POST compared to men. To defend the superiority of a larger tube size further studies assessing the effect of the ETT size on the arterial CO2 tension is needed.

Methods: After written, informed consent, 26 (13 in each group) consecutive, male patients planned for liver tumour ablation with HFJV will be included in the study.

Participants will be randomized to ETT size 8 or 9. Randomisation will take place in an earlier stage with the help of a computerised randomisation generator where 26 envelopes are prepared in which the information of tube size is to be found. The envelopes are on the outside anonymous. The envelopes will be opened by the anaesthetic nurse in the operation room, who will then prepare the ETT.

An arterial line will be placed before the start of anaesthesia and a transcutaneous measuring device will be placed on the forehead of the patient. After preoxygenation, induction and ETT placement, conventional ventilation will be started and a normal tcCO2 value reached (tcCO2 4,5-5 before the start of HFJV). HFJV will have pre-set settings with the same values for all patients. Driving pressure (DP) will be 1,2 bar and frequency 220/min. Measurements from the three different methods; arterial pCO2, transcutaneous CO2 and etCO2 will then be recorded at the start of HFJV (t=0) and then every 15' until t=45 minutes of HFJV. In the case of rapidly increasing CO2, a cut off limit of 10 kPa will be used. When this level is reached, settings on the ventilator will be changed. That means increasing DP and, if needed, lower the frequency. If this does not lead to a satisfactory CO2-level HFJV has to be changed to conventional ventilation until the CO2-level is within normal limits. Any injury during intubation and post extubation stridor (PES) will be recorded. The patient will be asked for post operative sore throat (POST) and any signs of postoperative hoarseness (PH) will be noted in the protocol before leaving the post anaesthetic care unit (PACU) and also approximately 24 hrs after extubation. If symptoms still occur after 24 hrs, follow up will take place approximately 72 hrs and 96 hrs after extubation. If symptoms are still present by this point the patient will be offered a doctor's appointment.

Statistics: The power calculation was based on data from previous studies. The base-line PaCO2 among 12 male patients, at the start of HFJV, was 4.9 kPa (SD 0.5) with an increase to mean PaCO2 of 6.7 (SD 1.5) at 15 minutes with HFJV and a tube size of 9. With the hypothesis that the PaCO2 would increase to a mean of 8.0 kPa after 15 minutes of HFJV ventilation, with a tube size 8, groups of 11 patients are needed to verify the difference at a p\<0.05 with a power of 80%. To compensate for potential drop-outs, groups of 13 patients is set as the study population. Data will be presented as mean, SD, median and range where applicable. One-way ANOVA will be used on normal distributed data and ANOVA on ranks will be used on non-normal distributed data. Bonferroni's test will be used to compare differences between the different timepoints. A p-value of \<0,05 will be considered as statistically significant.

Importance of the study: This study is conducted to if the larger endotracheal tube size has benefits in gas exchange when HFJV is being used in liver tumour ablation procedures. Normally it is desirable to use as small ETT as possible as this minimises the risks for airway injury. The risks of air entrapment and even pneumothorax and raise in carbon dioxide levels are also risks that are potentially harmful for the patients and must be avoided. The small risk of using a one size larger ETT would therefore be accepted if the benefits can be shown in this study.

Patients planned for liver tumour ablation will be randomised to one of two sizes of ETT, size 8 or size 9.

The patient is not being informed what ETT-size is being used.

As men and women routinely uses two different ETT sizes and we wanted to compare two sizes within one group, this study will only focus on men.

Endotracheal Tube Size Effect on the Carbon Dioxide Washout During Jet Ventilation

Does Endotracheal Tube (ETT) Size Facilitate Carbon Dioxide Washout in Liver Tumour Ablation With High Frequency Jet Ventilation (HFJV)? - a Randomised Controlled Trial

Carbon dioxide level from an arterial line (PaCO2) in kPa will be compared from the levels at baseline to the level at 15 minutes of HFJV.

The dynamics of carbon dioxide changes obtained from an arterial line (PaCO2) in kPa, transcutaneously (tcCO2) in kPa and end tidal measurement (etCO2) in kPa registered every 15 minutes during the first 45 minutes of HFJV. That is, all values from each timepoint (15 minutes, 30 minutes and 45 minutes after the start of HFJV) will be compared to baseline.

During HFJV measure pause pressure (PP) in mbar and peak pressure in mbar .

PaO2 in kPa will also be measured and analysed during the procedure.

pH will also be measured and analysed during the procedure.

Lactate in mmol/L will also be measured and analysed during the procedure.

Saturation in percent will also be measured and analysed during the procedure.

Signs of apparent mechanical injury in the airway. Signs of apparent injury, being visible injury during intubation and post extubation stridor (PES). Post operative sore throat (POST) and any signs of postoperative hoarseness (PH)

Region Stockholm

Fluorodeoxyglucose F18

Radiopharmaceuticals

This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only

N-13 ammonia or F-18 fluorodeoxyglucose

PET scan

Paul B. Shyn, M.D.

In this research study, the investigators are evaluating whether ammonia PET scans or FDG PET perfusion scans are more useful in helping radiologists determine whether liver tumors were successfully destroyed by the heating or freezing procedures (ablations) than other scans currently available to radiologists, such as CT scans and MRI scans.

The currently available scan (usually a CT scan with contrast dye) is not always effective in showing how completely the tumor has been destroyed. The ammonia PET scan is a different way of looking at how much tumor has been destroyed. This study will compare the standard scan (CT scan) with the ammonia PET scan.

The plan for this study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia or F-18 fluorodeoxyglucose to image liver perfusion with a PET scanner is the research portion of the procedure. The patient will receive one or two doses of N-13 ammonia (10 mCi (millicurie)/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only. The ammonia perfusion scan will not be used to change or modify the ablation procedure.

After the screening procedures confirm that that the participant is eligible to participate in the research study:

* Ammonia Perfusion PET: The participant will be scheduled for the tumor ablation procedure as part of the participant's routine care. If the participant decided to take part in this research study, then the participant will have one or two ammonia perfusion PET scans during the ablation procedure to see if the ablation was successful or not as compared to standard CT scanning. The ammonia perfusion PET scans are the research part of the participant's procedure. The rest of the participant's procedure is not research. The participant will receive one or two doses of the radioactive tracer called N-13 ammonia. This tracer is administered through the same IV (thin tube placed in a vein) used by the Anesthesiologist to give the participant routine medications that relax the participant, prevent pain, and allow the participant to sleep during the procedure. This tracer does not treat the participant's tumor in any way. Instead, the tracer may allow the radiologist to better see how much of the participant's tumor was destroyed.
* Photographs: Photographs may be taken during the procedure. Care will be taken to ensure these do not reveal the participant's identity.
* Clinic visits: The investigators routinely see patients after tumor ablation procedures within one to two weeks after the procedure and then every three months after the procedure for one to two years, and as needed in the future. Accordingly, the clinic visits are routine and not an added research commitment.

This is a diagnostic imaging study, involving FDA-approved radiopharmaceuticals. Applying a "Phase" to the study is N/A, even though the Study Phase had to be entered above.

PET/CT-Assessment of Liver Tumor Ablation

PET/CT-Guided Liver Tumor Ablation: Intraprocedural Assessment of Results Using Ammonia Perfusion PET

For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated.

Percentage of tumors with an inadequate margin on PET that progressed locally? Compare to MRI?

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Principal Investigator

This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only

N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer

PET scan: PET scan

N-13 Ammonia to Image Liver PET Perfusion

N-13 Ammoniaor F-18 Fluorodeoxygl to Image Liver PET Perfusion

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

There were 27 unique participants and one participant participated twice (in both interventions).

Paul Shyn, MD

Total Tumors

Assessibility of ablation margin by Pet Perfusion

Assessibility of ablation margin by MRI

N-13 Ammonia or F-18 to Image Liver PET Perfusion

In this study, the number of tumors were analysed. There 8 participants with 11 tumors that were analysed for N-13 ammonia to image liver PET perfusion and 31 tumors in 20 patients were analysed in F-18 fluorodeoxyglucose to image liver PET perfusion. 1 participant participated in both interventions. Total unique participants 27.

Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endotracheal Tube Size Effect on the Carbon Dioxide Washout During Jet Ventilation	NCT05370001	Liver Tumor	Entotracheal tu...	18 Years -	Region Stockholm
PET/CT-Assessment of Liver Tumor Ablation	NCT02018107	Liver Tumor Liver Neoplasms	N-13 ammonia or... PET scan	18 Years -	Dana-Farber Cancer Institute
Endotracheal Tube Size Effect on the Carbon Dioxide Washout During Jet Ventilation	NCT05370001	Liver Tumor	Entotracheal tu...	18 Years -	Region Stockholm
Endotracheal Tube Size Effect on the Carbon Dioxide Washout During Jet Ventilation	NCT05370001	Liver Tumor	Entotracheal tu...	18 Years -	Region Stockholm

Spots Global Cancer Trial Database for liver tumor ablation