Hyperspectral Imaging in Thoracic Surgery

Tissue Oxygenation Clinical Trial

— PILOT-Tx-HSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784884
• Other study ID #: PILOT-Tx-HSI
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: April 7, 2021

Study information

• Verified date: April 2021
• Source: LungenClinic Grosshansdorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 7, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• lung resection or other resection via thoracotomy

Exclusion Criteria:

• Restriction of the ability to consent

Related Conditions & MeSH terms

• Bronchus Anastomosis
• Bronchus Stump
• Tissue Oxygenation

Intervention

Device:
• HSI
diagnostic hyperspectral imaging

Locations

Country	Name	City	State
Germany	LungenClinic Großhansdorf	Großhansdorf

Sponsors (1)

Lead Sponsor	Collaborator
LungenClinic Grosshansdorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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