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

NCT05370001 | Completed

• 1 other identifier: ETT-size Karolina Galmén
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Tumor

Keywords

high frequency jet ventilation; endotracheal tube size; carbon dioxide; liver tumor ablation

Outcome Measures

Primary Outcomes (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.

  15 minutes after the start of HFJV

Secondary Outcomes (7)

• Dynamics of carbon dioxide during surgery using HFJV

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

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

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

• Analysing PaO2

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

• Analysing pH

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

• Analysing lactate

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

Study Arms (2)

Routine procedure - use of ETT size 9

NO INTERVENTION

When 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 8

EXPERIMENTAL

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.

Other: Entotracheal tube size

Interventions

Entotracheal tube size OTHER

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

Experimental group - use of ETT size 8

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Danderyd Hospital

Stockholm, Sweden

Location

Related Publications (9)

• 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.

  PMID: 24819833 BACKGROUND

• 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.

  PMID: 23636246 BACKGROUND

• 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.

  PMID: 19346232 BACKGROUND

• 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.

  PMID: 27762601 BACKGROUND

• 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.

  PMID: 28804874 BACKGROUND

• 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.

  PMID: 31583085 BACKGROUND

• 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.

  PMID: 20237758 BACKGROUND

• 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.

  PMID: 19930246 BACKGROUND

• 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.

  PMID: 9135179 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Klara Bergmark, MD

  Region Stockholm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient is not being informed what ETT-size is being used.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 11, 2022
• Study Start: June 13, 2022
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: February 13, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)