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NCT Number: NCT03378752

Atelectasis Formation Using HFJV During Stereotactic Solid Organ Ablations

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.

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Key information

Conditions

High Frequency Jet Ventilation Atelectasis Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institute Danderyd Hospital

Stockholm, 18288, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HFJV

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Atelectasis Formation Using High Frequency Jet Ventilation During Stereotactic Solid Organ Ablations

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2017
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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