Complications of Perfusion Clinical Trial
Official title:
Real-time Quantitative Optical Perfusion Imaging in Surgery: a Prospective, Observational, In-vivo, Human, Single-center Study
| Verified date | February 2018 |
| Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in
real-time during surgery. Complications due to vascular compromise are a major problem,
especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue
necrosis. If, however, perfusion and ischemia could be monitored during surgery, then
surgeons could change their reconstructive design and the anaesthesiologists could improve
perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a
tool that is able to image in high resolution (microvascularisation), direct,
intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying
vessels) and that produces quantitative data to objectify image interpretation.
Optical techniques, based on the interaction of light with tissue, are able to image tissue
at high resolution and in real-time. These techniques are FDA-approved and have emerged as
powerful diagnostic tools in different departments of medicine, such as ophthalmology for
visualizing retina vascularisation and dermatology for skin diagnostics.
In this study, investigators hypothesize that four novel optical technologies: Fluorescence
Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream
Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | December 2017 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: - Allergic to iodide (indocyanine green) - Hyper-thyroidism - Breastfeeding - No informed consent - Allergic to ephedrine - Ischaemic heart disease - Thyrotoxicosis - Autonomic thyroid adenomas - Intraoperative hypertension or tachycardia |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Academic Medical Center | Amsterdam |
| Lead Sponsor | Collaborator |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Quest Medical Imaging |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT. | - Perfusion will be imaged with OCT and measured in total vessel density. | 1 year | |
| Primary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF. | Perfusion will be imaged with SDF and measured in microvascular flow index. | 1 year | |
| Primary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with LSCI. | flux in perfusion units (LSCI) | 1 year | |
| Primary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with FI. | intensity/time (FI) | 1 year | |
| Secondary | Distance of watershed to fundus (GT) or artery to tip (flap) | In the FI images the distance between the end of the right gastroepiploic artery and the fundus, and the distance between the artery entry and tip of the flap can be calculated. | 1 year | |
| Secondary | Measurement-time during surgery | time in minutes will be calculated during measurements | 30 minutes | |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 year | ||
| Secondary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT. | - Perfusion will be imaged with OCT and measured in decorrelation time. | 1 year | |
| Secondary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF. | Perfusion will be imaged with SDF and measured in total vessel density. | 1 year | |
| Secondary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF. | Perfusion will be imaged with SDF and measured in perfused vessel density. | 1 year | |
| Secondary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF. | Perfusion will be imaged with SDF and measured in proportion of perfused vessels. | 1 year | |
| Secondary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF. | Perfusion will be imaged with SDF and measured in De Backer Score. | 1 year | |
| Secondary | Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF. | Perfusion will be imaged with SDF and measured in velocity in mm/sec. | 1 year |