Skip to main content
OpenTrials
Completed

NCT Number: NCT04784884

Hyperspectral Imaging in Thoracic Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchus Anastomosis Bronchus Stump Tissue Oxygenation

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LungenClinic Großhansdorf

Großhansdorf, 22927, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • lung resection or other resection via thoracotomy

Exclusion criteria

  • Restriction of the ability to consent

Treatment and study plan

HSI

Device

diagnostic hyperspectral imaging

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

LungenClinic Grosshansdorf

Other

Registry information

Official study 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

Acronym: PILOT-Tx-HSI

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.