Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43865
Enrollment
60
Registered
2016-10-28
Start date
2015-10-20
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

poor blood perfusion during Surgery Vascular Compromise

Interventions

Perfusion
Surgery

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To assess the reliability of the techniques we will focus on the interobserver agreements. We will score the images on the following 5 specific hemodynamic parameters, tailored to the specific characteristics of the devices. To explore the validity of the techniques we will compare the differences in images of good versus sparse blood flow in terms of the same parameter.

Secondary

MeasureTime frame
To technical compare the four imaging modalities in terms of resolution, imaging depth and field of view.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)