Hyperspectral Imaging in Thoracic Surgery (PILOT-Tx-HSI)

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

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

Study Overview

• Status: Completed
• Conditions: Tissue Oxygenation; Bronchus Anastomosis; Bronchus Stump
• Intervention / Treatment: Device: HSI

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Großhansdorf, Germany, 22927
    • LungenClinic Grosshansdorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• lung resection or other resection via thoracotomy

Exclusion Criteria:

• Restriction of the ability to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HSI-Pilot; Diagnostic hyperspectral imaging of the bronchus stump or bronchus anastomosis after lung resection and calculating the stump or anastomotic Perfusion measures, respectively	Device: HSI; diagnostic hyperspectral imaging

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LungenClinic Grosshansdorf
• Investigators: Principal Investigator: David B. Ellebrecht, MD, LungenClinic Grosshansdorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2021
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): April 7, 2021

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PILOT-Tx-HSI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No