Liver Tumor Clinical Trial
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
Verified date | May 2022 |
Source | Region Stockholm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 26, 2023 |
Est. primary completion date | January 26, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Patients with known CO2 retention. - Patients shorter than 160 cm (as an endotracheal tube size 9 would then be too big). |
Country | Name | City | State |
---|---|---|---|
Sweden | Danderyd Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Region Stockholm |
Sweden,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 15 minutes after the start of HFJV | |
Secondary | 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. | From the start of HFJV up until 45 minutes after the start of HFJV | |
Secondary | During HFJV measure pause pressure (PP) and peak pressure . | During HFJV measure pause pressure (PP) in mbar and peak pressure in mbar . | From the start of HFJV up until 45 minutes after the start of HFJV | |
Secondary | Analysing PaO2 | PaO2 in kPa will also be measured and analysed during the procedure. | From the start of HFJV up until 45 minutes after the start of HFJV | |
Secondary | Analysing pH | pH will also be measured and analysed during the procedure. | From the start of HFJV up until 45 minutes after the start of HFJV | |
Secondary | Analysing lactate | Lactate in mmol/L will also be measured and analysed during the procedure. | From the start of HFJV up until 45 minutes after the start of HFJV | |
Secondary | Analysing saturation | Saturation in percent will also be measured and analysed during the procedure. | From the start of HFJV up until 45 minutes after the start of HFJV | |
Secondary | 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) | At the most 96 hours post extubation. |
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