Hyperspectral Imaging in Thoracic Surgery

NCT ID: NCT04784884

Last Updated: 2022-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2021-04-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Bronchus Anastomosis Bronchus Stump Tissue Oxygenation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HSI-Pilot

Diagnostic hyperspectral imaging of the bronchus stump or bronchus anastomosis after lung resection and calculating the stump or anastomotic Perfusion measures, respectively

Group Type EXPERIMENTAL

HSI

Intervention Type DEVICE

diagnostic hyperspectral imaging

Interventions

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HSI

diagnostic hyperspectral imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* lung resection or other resection via thoracotomy

Exclusion Criteria

* Restriction of the ability to consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LungenClinic Grosshansdorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David B. Ellebrecht, MD

Role: PRINCIPAL_INVESTIGATOR

LungenClinic Grosshansdorf

Locations

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LungenClinic Großhansdorf

Großhansdorf, , Germany

Site Status

Countries

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Germany

References

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Ellebrecht DB, Kugler C. Intraoperative Determination of Bronchus Stump and Anastomosis Perfusion with Hyperspectral Imaging. Surg Innov. 2023 Jun;30(3):314-323. doi: 10.1177/15533506231157165. Epub 2023 Feb 21.

Reference Type DERIVED
PMID: 36802983 (View on PubMed)

Other Identifiers

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PILOT-Tx-HSI

Identifier Type: -

Identifier Source: org_study_id

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