Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging

NCT04660162 | Completed DMC

• 1 other identifier: NL65747.101.18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The microcirculation plays a fundamental role in metabolic reactions and has been shown as an essential determinant in many clinical scenarios such as shock states, chronic and cardio-metabolic diseases. Microcirculation can be assessed directly using laser-based techniques and intravital microscopes. When combined with provocation tests, microvascular monitorization can be used to assess microvascular function. Laser-based techniques are consist of two different methods named laser doppler imaging (LDI), laser speckle contrast imaging (LSCI). LSCI is a technique based on speckle contrast analysis that provides an index of blood flux. No need for skin contact, continuous and real-time assessment of the microcirculation led the LSCI to be broadly used in clinical practice. LDI is also a non-invasive diagnostic method used to measure the blood flux of tissue. The technique is based on measuring the doppler shift induced by moving red blood cells to the illuminating coherent light. Iontophoresis is one of the most commonly used provocation tests to study the endothelium in terms of endothelium-dependent and endothelium-independent vasodilation. Simultaneously with LDI and LSCI are used to follow and assess the skin blood flux during iontophoresis. Therefore, it provides a state to make a comparison between two different laser-based techniques in terms of flux characteristics. The accurate assessment of burn depth is a critical step in the management of the burn-injured patient. Currently, LDI is the most widely used non-invasive measurement tool for assessing burn wounds and the only technique approved by the U.S. Food and Drug Administration. However, the LDI device is rather costly, cumbersome, and has a poor spatial resolution. LSCI measures perfusion in a similar way, but it provides high-quality images with a much higher spatial resolution. In addition, LSCI is much quicker, maneuverable, and able to assess larger skin areas. In order to use the LSCI technique in the clinical practice of burn-injured patients, as a first step, the linearity of LDI and LSCI should be shown. In this study, we aimed to compare LSCI and LDI with iontophoresis and stepwise occlusion technique. So, we will test the linearity of devices over a large range of blood flux values.

Conditions

Microcirculation

Keywords

microcirculation; laser speckle contrast imaging; laser doppler perfusion imaging; iontophoresis; comparison; flux

Outcome Measures

Primary Outcomes (1)

• Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging

  Blood flux values of Laser Speckle Contrast Imaging device (Perimed AB, Järfälla, Sweden) and Laser Doppler Imaging device (Moor Instruments, Devon, UK) will be measured in a wide range of blood flux values and an equation formula will be described

  60 minutes

Secondary Outcomes (2)

• Creating common unit for Laser Speckle Contrast Imaging and Laser Doppler Imaging

  60 minutes

• Creating common color map for Laser Speckle Contrast Imaging and Laser Doppler Imaging

  60 minutes

Study Arms (2)

Arm-1: Laser speckle contrast imaging

EXPERIMENTAL

(Perimed AB, Järfälla, Sweden)

Device: Iontophoresis; Other: Stepwise occlusion

Arm-2: Laser Doppler perfusion imaging

EXPERIMENTAL

(Moor Instruments, Devon, UK)

Device: Iontophoresis; Other: Stepwise occlusion

Interventions

Iontophoresis DEVICE

By using the PeriIont (Perimed, Jarfalla, Sweden) device, 0.5 mL of a 10 mg/ml Sodium nitroprusside solution was used transdermally and ionised with a current strength of 200 µA for 1 minute.

Arm-1: Laser speckle contrast imaging; Arm-2: Laser Doppler perfusion imaging

Stepwise occlusion OTHER

The upper arm was occluded for 30 seconds with a pneumatic cuff up to 50 mmHg, 80 mmHg, 110 mmHg, 140 mmHg, and 170 mmHg. The volunteer had rest for 5 minutes between each occlusion procedure.

Arm-1: Laser speckle contrast imaging; Arm-2: Laser Doppler perfusion imaging

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Should not have any disease at the time of procedure (including flu)
• Should not have any chronic disease
• Should not be under any medication
• Should not be smoker or ex-smoker
• Should not drink coffee or eat meal in two hours before the procedure
• Should not have an allergy to sodium-nitroprusside

You may not qualify if:

• Volunteer who does not meet any of the criteria above
• \<18 years old
• Pregnant
• Refusal to participate in the study or demand to end study for any reason
• Hypersensitivity to sodium nitroprusside
• Broken or damaged skin surfaces
• Electrically-sensitive implanted devices such as cardiac pacemakers
• Maastad Ziekenhuis employers or collegues

Sponsors & Collaborators

• Maasstad Hospital: lead

Study Sites (1)

Maasstad Ziekenhuis

Rotterdam, South Holland, 3007AC, Netherlands

Location

Related Publications (11)

• Sakr Y. Techniques to assess tissue oxygenation in the clinical setting. Transfus Apher Sci. 2010 Aug;43(1):79-94. doi: 10.1016/j.transci.2010.05.012. Epub 2010 Jun 17.

  PMID: 20692624 BACKGROUND

• Briers JD. Laser Doppler, speckle and related techniques for blood perfusion mapping and imaging. Physiol Meas. 2001 Nov;22(4):R35-66. doi: 10.1088/0967-3334/22/4/201.

  PMID: 11761081 BACKGROUND

• Tew GA, Klonizakis M, Crank H, Briers JD, Hodges GJ. Comparison of laser speckle contrast imaging with laser Doppler for assessing microvascular function. Microvasc Res. 2011 Nov;82(3):326-32. doi: 10.1016/j.mvr.2011.07.007. Epub 2011 Jul 22.

  PMID: 21803051 BACKGROUND

• Stewart CJ, Frank R, Forrester KR, Tulip J, Lindsay R, Bray RC. A comparison of two laser-based methods for determination of burn scar perfusion: laser Doppler versus laser speckle imaging. Burns. 2005 Sep;31(6):744-52. doi: 10.1016/j.burns.2005.04.004.

  PMID: 16129229 BACKGROUND

• Millet C, Roustit M, Blaise S, Cracowski JL. Comparison between laser speckle contrast imaging and laser Doppler imaging to assess skin blood flow in humans. Microvasc Res. 2011 Sep;82(2):147-51. doi: 10.1016/j.mvr.2011.06.006. Epub 2011 Jul 1.

  PMID: 21745482 BACKGROUND

• Cordovil I, Huguenin G, Rosa G, Bello A, Kohler O, de Moraes R, Tibirica E. Evaluation of systemic microvascular endothelial function using laser speckle contrast imaging. Microvasc Res. 2012 May;83(3):376-9. doi: 10.1016/j.mvr.2012.01.004. Epub 2012 Jan 31.

  PMID: 22326551 BACKGROUND

• Tesselaar E, Sjoberg F. Transdermal iontophoresis as an in-vivo technique for studying microvascular physiology. Microvasc Res. 2011 Jan;81(1):88-96. doi: 10.1016/j.mvr.2010.11.002. Epub 2010 Nov 9.

  PMID: 21070791 BACKGROUND

• Wearn C, Lee KC, Hardwicke J, Allouni A, Bamford A, Nightingale P, Moiemen N. Prospective comparative evaluation study of Laser Doppler Imaging and thermal imaging in the assessment of burn depth. Burns. 2018 Feb;44(1):124-133. doi: 10.1016/j.burns.2017.08.004. Epub 2017 Oct 9.

  PMID: 29032974 BACKGROUND

• Iredahl F, Lofberg A, Sjoberg F, Farnebo S, Tesselaar E. Non-Invasive Measurement of Skin Microvascular Response during Pharmacological and Physiological Provocations. PLoS One. 2015 Aug 13;10(8):e0133760. doi: 10.1371/journal.pone.0133760. eCollection 2015.

  PMID: 26270037 BACKGROUND

• Ince C. The microcirculation is the motor of sepsis. Crit Care. 2005;9 Suppl 4(Suppl 4):S13-9. doi: 10.1186/cc3753. Epub 2005 Aug 25.

  PMID: 16168069 RESULT

• Klijn E, Den Uil CA, Bakker J, Ince C. The heterogeneity of the microcirculation in critical illness. Clin Chest Med. 2008 Dec;29(4):643-54, viii. doi: 10.1016/j.ccm.2008.06.008.

  PMID: 18954699 RESULT

MeSH Terms

Interventions

Iontophoresis

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Study Officials

• Kees vd Vlies, MD

  Maasstad Hospital, Department of Burn Care

  STUDY DIRECTOR

• Can Ince, Phd

  Erasmus Medical Center, Department of Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Research assistant in the Burn Unit of Maasstad Hospital

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 9, 2020
• Study Start: December 10, 2018
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

NL (1)