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Liver TumorNCT05370001

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

A study testing Entotracheal tube size in people with Liver Tumor, run by Region Stockholm at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Liver Tumor
What is being tested?
Entotracheal tube size
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSweden
Study dates
13 Jun 2022to 26 Jan 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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male patients scheduled for stereotactic liver tumour ablation.
  • Need for an arterial line for safe monitoring of hemodynamic and respiratory variables during the procedure/anaesthesia.
  • Ability to understand the information about the study and be able to leave a written, informed consent.

Who cannot join

  • Patients with known CO2 retention.
  • Patients shorter than 160 cm (as an endotracheal tube size 9 would then be too big).

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Danderyd Hospital

    Stockholm

Other trials in Sweden

About this study

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

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.

Read the detailed description

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.

Conditions
Liver Tumor
Being tested
Entotracheal tube size
Keywords
high frequency jet ventilation, endotracheal tube size, carbon dioxide, liver tumor ablation
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Entotracheal tube sizeOther

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

Study groups in NCT05370001
Study groupRoleWhat they receive
Routine procedure - use of ETT size 9No interventionWhen using HFJV in liver tumour ablation procedures for optimizing surgical conditions, an ETT size 9 is routinely being used in our department.
Experimental group - use of ETT size 8ExperimentalIn 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.
Receives: Other: Entotracheal tube size

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Carbon dioxide level from an arterial line (PaCO2) after 15 minutes of HFJV.

    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.

    Measured: 15 minutes after the start of HFJV

Secondary outcomes (7)
  1. Dynamics of carbon dioxide during surgery using 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.

    Measured: From the start of HFJV up until 45 minutes after the start of HFJV

  2. During HFJV measure pause pressure (PP) and peak pressure .

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

    Measured: From the start of HFJV up until 45 minutes after the start of HFJV

  3. Analysing PaO2

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

    Measured: From the start of HFJV up until 45 minutes after the start of HFJV

  4. Analysing pH

    pH will also be measured and analysed during the procedure.

    Measured: From the start of HFJV up until 45 minutes after the start of HFJV

  5. Analysing lactate

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

    Measured: From the start of HFJV up until 45 minutes after the start of HFJV

  6. Analysing saturation

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

    Measured: From the start of HFJV up until 45 minutes after the start of HFJV

  7. Injury of the airway following endotracheal intubation.

    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)

    Measured: At the most 96 hours post extubation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2022
  2. Study start13 Jun 2022
  3. Primary completion26 Jan 2023
  4. Study completion26 Jan 2023

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients planned for liver tumour ablation will be randomised to one of two sizes of ETT, size 8 or size 9.
Masking
Single blind
Who is masked
Participant
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05370001
Sponsor's protocol ID
ETT-size Karolina Galmén
Status last verified
May 2022
First submitted
25 Apr 2022
Last updated
13 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chung DY, Tse DM, Boardman P, Gleeson FV, Little MW, Scott SH, Anderson EM. High-frequency jet ventilation under general anesthesia facilitates CT-guided lung tumor thermal ablation compared with normal respiration under conscious analgesic sedation. J Vasc Interv Radiol. 2014 Sep;25(9):1463-9. doi: 10.1016/j.jvir.2014.02.026. Epub 2014 May 10.

    PubMed 24819833
  • Denys A, Lachenal Y, Duran R, Chollet-Rivier M, Bize P. Use of high-frequency jet ventilation for percutaneous tumor ablation. Cardiovasc Intervent Radiol. 2014 Feb;37(1):140-6. doi: 10.1007/s00270-013-0620-4. Epub 2013 May 2.

    PubMed 23636246
  • Biro P, Spahn DR, Pfammatter T. High-frequency jet ventilation for minimizing breathing-related liver motion during percutaneous radiofrequency ablation of multiple hepatic tumours. Br J Anaesth. 2009 May;102(5):650-3. doi: 10.1093/bja/aep051. Epub 2009 Apr 3.

    PubMed 19346232
  • Engstrand J, Toporek G, Harbut P, Jonas E, Nilsson H, Freedman J. Stereotactic CT-Guided Percutaneous Microwave Ablation of Liver Tumors With the Use of High-Frequency Jet Ventilation: An Accuracy and Procedural Safety Study. AJR Am J Roentgenol. 2017 Jan;208(1):193-200. doi: 10.2214/AJR.15.15803. Epub 2016 Oct 20.

    PubMed 27762601
  • Galmen K, Harbut P, Freedman J, Jakobsson JG. High frequency jet ventilation for motion management during ablation procedures, a narrative review. Acta Anaesthesiol Scand. 2017 Oct;61(9):1066-1074. doi: 10.1111/aas.12950. Epub 2017 Aug 13.

    PubMed 28804874
  • Galmen K, Jakobsson JG, Freedman J, Harbut P. High Frequency Jet Ventilation during stereotactic ablation of liver tumours: an observational study on blood gas analysis as a measure of lung function during general anaesthesia. F1000Res. 2019 Apr 5;8:386. doi: 10.12688/f1000research.18369.1. eCollection 2019.

    PubMed 31583085
  • Tadie JM, Behm E, Lecuyer L, Benhmamed R, Hans S, Brasnu D, Diehl JL, Fagon JY, Guerot E. Post-intubation laryngeal injuries and extubation failure: a fiberoptic endoscopic study. Intensive Care Med. 2010 Jun;36(6):991-8. doi: 10.1007/s00134-010-1847-z. Epub 2010 Mar 18.

    PubMed 20237758
  • Jaensson M, Olowsson LL, Nilsson U. Endotracheal tube size and sore throat following surgery: a randomized-controlled study. Acta Anaesthesiol Scand. 2010 Feb;54(2):147-53. doi: 10.1111/j.1399-6576.2009.02166.x. Epub 2009 Nov 23.

    PubMed 19930246
  • Myles PS, Hunt JO, Moloney JT. Postoperative 'minor' complications. Comparison between men and women. Anaesthesia. 1997 Apr;52(4):300-6. doi: 10.1111/j.1365-2044.1997.89-az0091.x.

    PubMed 9135179

Questions about this trial

What is this clinical trial studying?

A study testing Entotracheal tube size in people with Liver Tumor, run by Region Stockholm 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 3 inclusion and 2 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 13 Feb 2023. 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?

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?

Carbon dioxide level from an arterial line (PaCO2) after 15 minutes of HFJV. (time frame: 15 minutes after the start of HFJV). 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 NCT05370001, which also lists 9 linked publications.

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 13 Feb 2023.

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