NCT04784884

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2021

Completed
Last Updated

June 6, 2022

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

February 25, 2021

Last Update Submit

June 3, 2022

Conditions

Bronchus AnastomosisBronchus StumpTissue Oxygenation

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

HSI-Pilot

EXPERIMENTAL

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

Device: HSI

Interventions

HSIDEVICE

diagnostic hyperspectral imaging

HSI-Pilot

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lung resection or other resection via thoracotomy

You may not qualify if:

  • Restriction of the ability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LungenClinic Großhansdorf

Großhansdorf, 22927, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36802983DERIVED

Study Officials

  • David B. Ellebrecht, MD

    LungenClinic Grosshansdorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 5, 2021

Study Start

January 21, 2021

Primary Completion

March 31, 2021

Study Completion

April 7, 2021

Last Updated

June 6, 2022

Record last verified: 2021-04

Locations

DE(1)