Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns. (POTER-DIC)
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|ClinicalTrials.gov Identifier: NCT02736838|
Recruitment Status : Unknown
Verified May 2017 by JOSE MIGUEL MORALES ASENCIO, University of Malaga.
Recruitment status was: Enrolling by invitation
First Posted : April 13, 2016
Last Update Posted : May 8, 2017
Objectives: 1. To analyze the changes in peripheral tissue oxygenation in tissues subjected to different pressure regimes in healthy humans. 2. To analyze changes in microvascular flow in peripheral tissues subjected to different pressure regimes in healthy humans. 3. To determine thresholds of tissue perfusion flow and transcutaneous oxygen depending on exposure levels and angling pressure in healthy volunteers. 4. To evaluate the distribution of tissue perfusion flow and transcutaneous oxygenation in real clinical situations in residential care and acute hospital care in patients at risk for impaired skin integrity.
Experimental non-controlled, non-randomized study in two phases: preclinical and clinical. The first phase, will be conducted in healthy volunteers and the second, in patients at risk for impaired skin integrity. Vascular flow, tissue oxygenation and local temperature in areas at risk of pressure ulcers by Doppler laser will be evaluated in subjects lying on a capacitive surface to measure pressure with 10,249 points of measurement, which will be subject to different body systems to generate different levels of pressure and monitor changes in tissue perfusion and oxygenation up to 4 hours, to know the implications for repositioning interventions in patients at risk.
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer||Device: tcpO2 Device: Laser Doppler||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns. A Phase I Trial (POTER-DIC)|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||March 2019|
Experimental: Phase I
Interventions: Different positions will be applied to subjects to measure preipheral tissue oxygenation, pressure, and changes in microvascular flow. Subjects will be placed up to 4 hours in each of the standard positions for the experiment: supine decubitus (SD) right lateral decubitus (RLD), left lateral decubitus (LLD). SD measurements will be made at 0, 30 and 45 degrees of inclination to bed. RLD and LLD positions will be evaluated with a body inclination of 30 and 90ª. The subjects will lie down on a memory foam mattress for an articulated bed, as are commonly used at home, residential or hospital care. Between the subject and the mattress will be inserted the pressure measuring surface. Measurements in each position will be made during intervals of 0-4 hours in the same position (SD-RLD-LLD) in each of the inclinations of the bed (0º, 30°, 45 °) or body (30º, 90º), respectively.
Skin oxygenation will be measured by tcpO2, and microvascular flow with Laser Doppler. Measurements will be made inserting probes in sacrum, trochanters, elbows and heels, before and after the end of each decubitus lying period, and in every position and angle. Pressure: Continuous pressure measurements will be made in sacrum, trochanters, elbows and heels. Measures will be carried out at sessions separated at intervals of 7 days, with 0 to 4 hours of experimental exposure to pressure, different bed angles (0º, 30º, 45º), and lateral decubitus tilts (30, 90). Bioimpedance will be performed at baseline early in the morning, fasting and after emptying the bladder. Subjects will be lying without clothes, in a supine position on the bed, with a distance of at least 25 cm between thighs. The measurement will be made in single frequency mode (50 kHz , 400 μARMS) with a tetrapolar electrode arrangement.
Device: Laser Doppler
- Peripheral tissue oxygenation (transcutaneous oxygen) [ Time Frame: Change from Baseline in each four hour session of the eleven measurement periods along days 1-2-3-4-5. From September 2016 to May 2017 ]Local noninvasive measurement reflecting the amount of O2 that has diffused from the capillaries, through the epidermis to a Clark-tupe electrode at the measuring site.
- Microvascular flow in peripheral tissues [ Time Frame: Change from Baseline in each four hour session of the eleven measurement periods along days 1-2-3-4-5. From September 2016 to May 2017 ]Non invasive measurement through Laser Doppler, using a diode laser emitting continuous divergent radiation. The PeriFlux System 5000 equipped with PF 5010 LDPM Unit(s) is classified in USA as a class 1 laser product according to FDA CFR 1040.10. In Europe, the instrument is classified as a Class 1 laser product according to IEC 60825-1:2007. An optical fiber leads light generated by a laser to the LDPM probe tip, which rests against the tissue. The beam of light will enter the tissue and become scattered. Blood cells moving within the volume illuminated by the beam will cause the light to change frequency. This change in frequency is called a Doppler shift.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736838
|Principal Investigator:||Silvia García-Mayor, PhD||Faculty of Health Sciences, University of Málaga, Spain|