Hyperspectral Imaging in Thoracic Surgery

Not Applicable

Completed

• Conditions: Tissue Oxygenation; Bronchus Stump; Bronchus Anastomosis
• Interventions: Device: HSI

• Registration Number: NCT04784884
• Lead Sponsor: LungenClinic Grosshansdorf

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.

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Primary Completion: 2021-03-31
• Status Verified: 2021-04
• Study Completion: 2021-04-07
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• lung resection or other resection via thoracotomy

Exclusion Criteria

• Restriction of the ability to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSI-Pilot	HSI	Diagnostic hyperspectral imaging of the bronchus stump or bronchus anastomosis after lung resection and calculating the stump or anastomotic Perfusion measures, respectively

Primary Outcome Measures

Name	Time	Method
Oxygenation: Bronchus before lung resection	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	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	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	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	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	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	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	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

Trial Locations

Locations (1)

LungenClinic Großhansdorf; 🇩🇪 Großhansdorf, Germany