Atelectasis Formation Using HFJV During Stereotactic Solid Organ Ablations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03378752
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : August 8, 2018
Information provided by (Responsible Party):
Jacob Freedman, Karolinska Institutet

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.

Condition or disease Intervention/treatment
High Frequency Jet Ventilation Atelectasis Procedure: HFJV

Detailed Description:

The use of HFJV in abdominal surgery as well as in out-of-operating theatre environment, is not well studied. In percutaneous liver thermal ablation the patient is anesthetized and intubated on the CT-bed where the liver ablation procedure is performed. Atelectasis is formed as soon as the patient is supine. Anesthesia itself also contributes to this. In extreme cases almost half the lung can be collapsed during anaesthesia, before any surgery has taken place.

The investigators have noticed that during this specific surgery, dynamic lung compliance does not necessarily worsen during HFJV but rather being unchanged or in some cases even becoming better and want to study this further and investigate the formation of atelectasis during HFJV. There are studies where atelectasis has been measured in a similar way as in this planned study, that is, with thin axial CT-scans at representative levels of the lung. This is during conventional lung ventilation, and has not yet been studied during HFJV.

Inclusion criteria: A total of n= 25 patients planned for elective liver tumor thermal ablation will be recruited after written informed consent.

Exclusion criteria: Patients 1/ under the age of 50 years, 2/with severe, poorly controlled lung disease.

The lung images will be saved in DICOM format and the tissue density will be analysed quantitatively. For each scan, the inner contour of each hemithorax will be manually drawn, excluding the chest wall, mediastinum, pleural effusions, and regions representing partial volume effects. Liver displacement can be measured from the routine CT-scans taken before and after the procedure.

Statistical methods: Chi2-analysis will be used to calculate the percentage of atelectasis in the lung.

Power calculation: Since the rate of atelectasis formation in the study groups is not known, it is impossible to perform power calculation for this trial. This study may clarify this issue in the planning of further studies.

This study may contribute to more knowledge about HFJV and its' effect on lung physiology, it may also contribute as a generator of new hypothesis and it might be a follow up study where the effect of alveolar recruitment maneuver (ARM) is studied.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atelectasis Formation Using High Frequency Jet Ventilation During Stereotactic Solid Organ Ablations
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : December 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Group/Cohort Intervention/treatment
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
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)

Primary Outcome Measures :
  1. Change in formation of atelectasis during high frequency jet ventilation [ Time Frame: Time frame is during surgery. ]
    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.

Secondary Outcome Measures :
  1. Change of liver displacement [ Time Frame: Time frame is during surgery. ]
    Routine CT Scans taken during surgery will be studied to calculate liver displacement over time.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients referred for computed tomography guided ablation of liver tumours.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age < 50 years old. Severe lung disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03378752

Karolinska Institute Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Karolinska Institutet

Responsible Party: Jacob Freedman, Senior Consultant, Associate Professor, Karolinska Institutet Identifier: NCT03378752     History of Changes
Other Study ID Numbers: 2017/1158-32
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacob Freedman, Karolinska Institutet:
Computer tomography
Liver tumor thermoablation

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases