Hyperspectral Imaging in Thoracic Surgery

Study Overview
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Brief Summary
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The aim of this study is to find out whether hyperspectral imaging enables bronchus stump and bronchus anastomosis oxygenation.

Detailed Description
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The bronchus before lung resection and the bronchus stump or bronchus anastomosis, respectively, are investigated. The hyperspectral imaging camera head is placed and aligned over the surgical (camera and object distance: 30 cm for all measurements). The Field of view is illuminated by 8 halogen spots (20 W each) and 100 wavelengths in the wavelength range from 500 to 1000 nm were applied. The software calculates the tissue oxygenation [%] , organ-hemoglobin-index, near-infrared-Index and the tissue-water-index of the investigated tissue. The study was designed to investigate tissue oxygenation in the superficial (app. 1mm) and deeper layers (app. 4-6mm) of the bronchus before and after lung resection.

Official Title
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Pilot Study of Intraoperative Tissue Differentiation and Vascular Perfusion Using Intraoperative Hyperspectral Imaging (HSI) in Benign and Malignant Diseases of the Lung, Pleura and Mediastinum

Conditions
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Bronchus Anastomosis, Bronchus Stump, Tissue Oxygenation

Intervention / Treatment
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* Device: HSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lung resection or other resection via thoracotomy Exclusion Criteria: Restriction of the ability to consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSI-Pilot<br>Diagnostic hyperspectral imaging of the bronchus stump or bronchus anastomosis after lung resection and calculating the stump or anastomotic Perfusion measures, respectively | Device: HSI<br>* diagnostic hyperspectral imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation: Bronchus before lung resection | Tissue perfusion of the bronchus before lung resection: Oxygenation (StO2) in %: Relative O2 saturation of the blood in superficial tissue layers (penetration depth: approx. 1 mm) | directly before lung resection | 
| Oxygenation: Bronchus stump or bronchus anastomosis after lung resection | Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Oxygenation (StO2) in %: Relative O2 saturation of the blood the in superficial tissue layers (penetration depth: approx. 1 mm) | 10-15 minutes after lung resection | 
| Near Infrared Perfusion Index: Bronchus before lung resection | Tissue perfusion of the bronchus before lung resection: Near Infrared Perfusion Index: Tissue perfusion in deeper tissue layers (penetration depth: 4-6mm) | directly before lung resection | 
| Near Infrared Perfusion Index: Bronchus stump or bronchus anastomosis after lung resection | Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Near Infrared Perfusion Index: Tissue perfusion in deeper tissue layers (penetration depth: 4-6mm) | 10-15 minutes after lung resection | 
| Tissue-Hemoglobin index: Bronchus before lung resection | Tissue perfusion of the bronchus before lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue | directly before lung resection | 
| Tissue-Hemoglobin index: Bronchus stump or bronchus anastomosis after lung resection | Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue | 10-15 minutes after lung resection | 
| Tissue-Water-Index: Bronchus before lung resection | Tissue perfusion of the bronchus before lung resection: Tissue-Water-Index: Existing water distribution in the tissue | directly before lung resection | 
| Tissue-Water-Index: Bronchus stump or bronchus anastomosis after lung resection | Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Water-Index: Existing water distribution in the tissue | 10-15 minutes after lung resection |