NCT03378752

Brief Summary

Atelectasis formation using HFJV during stereotactic solid organ ablations. Primary endpoint will be to study the formation of atelectasis during HFJV. Secondary endpoint will be to study liver displacement over time. Reference groups will be found in previous published articles as referred to above. Materials and methods: A radiological protocol has been made for the CT-scanner to take 10 cm volume Scans of the lower part of the lung. The scans will have its' lower border tangential to the top of the diaphragm. The first scan will be performed in the same session as the routine scan of the liver is performed after the patient is anesthetized. These Scans will then be repeated every 15 minute during the first 45 minutes. Arterial bloodgas analysis, transcutaneous CO2, blood pressure, saturation as well as parameters from the jet ventilator and the standard ventilator will be recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

December 4, 2017

Last Update Submit

August 7, 2018

Conditions

High Frequency Jet VentilationAtelectasis

Keywords

Computer tomographyLiver tumor thermoablation

Outcome Measures

Primary Outcomes (1)

  • Change in formation of atelectasis during high frequency jet ventilation

    Computed tomography Scans will be taken during general anaesthesia at the start of jet ventilation, t=0, and then at t=15 minutes, t=30 minutes and t=45 minutes. A total number of four scans will be performed in each study subject.

    Time frame is during surgery.

Secondary Outcomes (1)

  • Change of liver displacement

    Time frame is during surgery.

Study Arms (1)

Atelectasis formation using HFJV

Computed tomography scans are performed every 15 minute during the first 45 minutes during general anaesthesia using high frequency jet ventilation.

Procedure: HFJV

Interventions

HFJVPROCEDURE

On High frequency jet ventilation, Every 15 minutes, after induction of general anaesthesia, a computed tomography of the lower part of the lungs are taken (10 cm volume, with the top of the right diaphragm as the lower border)

Atelectasis formation using HFJV

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients referred for computed tomography guided ablation of liver tumours.

You may qualify if:

  • All consecutive patients admitted to and by the surgeon planned for liver thermal ablation with cascination navigation system (requiring high frequency jet ventilation) from start date 25th of October, until a total number of 25 patients are included.

You may not qualify if:

  • Age \< 50 years old. Severe lung disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institute Danderyd Hospital

Stockholm, 18288, Sweden

Location

Related Publications (4)

  • Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.

    PMID: 19809292BACKGROUND

  • 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: 23636246BACKGROUND

  • Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. doi: 10.1093/bja/aeg085. No abstract available.

    PMID: 12821566BACKGROUND

  • Abderhalden S, Biro P, Hechelhammer L, Pfiffner R, Pfammatter T. CT-guided navigation of percutaneous hepatic and renal radiofrequency ablation under high-frequency jet ventilation: feasibility study. J Vasc Interv Radiol. 2011 Sep;22(9):1275-8. doi: 10.1016/j.jvir.2011.04.013. Epub 2011 Jun 23.

    PMID: 21703873BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, Associate Professor

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 20, 2017

Study Start

October 2, 2017

Primary Completion

December 19, 2017

Study Completion

December 19, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

SE(1)