Real-time Quantitative Optical Perfusion Imaging in Surgery: A Prospective, Observational, In-vivo, Human, Single-Center Study.

Completed

• Conditions: poor blood perfusion during Surgery; Vascular Compromise; 10041297

• Registration Number: NL-OMON43865
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Age * 18 years
- Scheduled for reconstructive surgery with free flap reconstruction or
laparoscopic transhiatal and 3-stage transthoracic gastric tube surgery.

Exclusion Criteria

Both free flap surgery as gastric tube surgery:
- Allergic to iodide (indocyanine green)
- Hyper-thyroidism
- Breastfeeding
- No informed consent;In case of gastric tube surgery, and the use of ephedrine:
- Allergic to ephedrine
- Ischeamic heart disease
- Thyrotoxicosis
- Autonomic thyroid adenomas
- Intraoperative hypertension or tachycardia

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the reliability of the techniques we will focus on the interobserver<br /><br>agreements. We will score the images on the following 5 specific hemodynamic<br /><br>parameters, tailored to the specific characteristics of the devices. To explore<br /><br>the validity of the techniques we will compare the differences in images of<br /><br>good versus sparse blood flow in terms of the same parameter. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To technical compare the four imaging modalities in terms of resolution,<br /><br>imaging depth and field of view.</p><br>