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Clinical Trials/NCT04784884
NCT04784884
Completed
Not Applicable

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

LungenClinic Grosshansdorf1 site in 1 country25 target enrollmentJanuary 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchus Anastomosis
Sponsor
LungenClinic Grosshansdorf
Enrollment
25
Locations
1
Primary Endpoint
Oxygenation: Bronchus before lung resection
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 21, 2021
End Date
April 7, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
LungenClinic Grosshansdorf
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • lung resection or other resection via thoracotomy

Exclusion Criteria

  • Restriction of the ability to consent

Outcomes

Primary Outcomes

Oxygenation: Bronchus before lung resection

Time Frame: directly 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)

Near Infrared Perfusion Index: Bronchus before lung resection

Time Frame: directly 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)

Oxygenation: Bronchus stump or bronchus anastomosis after lung resection

Time Frame: 10-15 minutes 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)

Tissue-Hemoglobin index: Bronchus before lung resection

Time Frame: directly before lung resection

Tissue perfusion of the bronchus before lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue

Tissue-Water-Index: Bronchus stump or bronchus anastomosis after lung resection

Time Frame: 10-15 minutes after lung resection

Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Water-Index: Existing water distribution in the tissue

Tissue-Water-Index: Bronchus before lung resection

Time Frame: directly before lung resection

Tissue perfusion of the bronchus before lung resection: Tissue-Water-Index: Existing water distribution in the tissue

Near Infrared Perfusion Index: Bronchus stump or bronchus anastomosis after lung resection

Time Frame: 10-15 minutes 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)

Tissue-Hemoglobin index: Bronchus stump or bronchus anastomosis after lung resection

Time Frame: 10-15 minutes after lung resection

Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue

Study Sites (1)

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