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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
Sponsor:
Collaborator:
Health Service of Andalucia
Information provided by (Responsible Party):
JOSE MIGUEL MORALES ASENCIO, University of Malaga

Tracking Information
First Submitted Date  ICMJE February 25, 2016
First Posted Date  ICMJE April 13, 2016
Last Update Posted Date May 8, 2017
Study Start Date  ICMJE October 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02736838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns.
Official Title  ICMJE Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns. A Phase I Trial (POTER-DIC)
Brief Summary

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.

Methodology:

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.

Detailed Description

Sample: the preclinical phase will be conducted in 20 healthy volunteers enrolled in the Faculty of Health Sciences of the University of Malaga. Clinical phase will take place in 12 subjects admitted to acute hospitalization in 'Costa del Sol' Health Agency and 12 subjects admitted to nursing homes in the District of Primary Knowing this information will identify different thresholds start in peripheral microcirculation disorders associated with various systems of body position and consequent pressure levels. This particular seems a reasonable need from baseline parameters allow to further explore specific situations of tissue injury and isolate direct and indirect causal factors. It is also necessary to conduct the study in subjects from different environments (home, hospital) to determine under real clinical practice how these parameters behave and how it can affect common procedures performed in clinical practice, such as repositioning or using pressure surfaces. This sample of 24 subjects was calculated taking into account a change in the capillary flow of 30% between baseline and the first hour of exposure to pressure, according to data of Kallman et al. (15) with an 80% output and statistical confidence level of 95%. In total, each subject will provide a total of 28 hours of measurement.

Phase 1: Inclusion criteria:Healthy volunteers, between 20 and 65 years old, with no cardiovascular, neurological, digestive, endocrine, renal, gynecological, respiratory, hematologic, infectious, dermatological, autoimmune or diagnosed musculoskeletal disease or functional limitations, with tissue integrity and BMI between 18.5 to 25.9 kg/cm2 without scars in the sacred, back-lumbar, trochanteric, heels, elbows and shoulder blades areas.

Exclusion criteria: The usual consumption for any reason of alpha-beta-blocking agents, or alpha-beta agonists, or directly or indirectly vasodilator-vasoconstrictor action drugs of any kind, anticoagulants, topical or systemic steroids, presence of pacemakers or implantable defibrillator, smoking, high consumption of alcohol (>20g/week), presence of tattoos in the areas of measurement, and lower limb amputation

Phase 2: Inclusion criteria: Patients admitted to acute hospitalization, with risk of skin integrity deterioration assessed by Braden scale (punctuation lower than 16) without pressure ulcers, who agree to participate in the study. Exclusion criteria: presence infusion of vasoactive drugs at the time of the study (dopamine, epinephrine, norepinephrine, dobutamine, nitroprusside, nitroglycerin, calcium channel blockers, ACE inhibitors). Regular oral treatment of alpha and beta-blockers and/or agonists or calcium channel blockers, nitrates, ACE inhibitors, angiotensin, renin inhibitors, diuretics, SSRIs, NSAIDs, will be accepted. Also patients with pacemakers and/or implanted defibrillator, fever, anemia with Hb <10g/dl, hypotension with systolic blood pressure <80 mmHg, presence of transfusions in the past 4 weeks, consumption and derivatives of erythropoietin, iron supplements, oral or parenteral anticoagulants will be excluded.

Interventions: Different positions will be applied to subjects in order to measure preipheral tissue oxygenation, pressure, and changes in microvascular flow.

The subject will be placed 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 90 degrees, aided by pillows, as is done in routine clinical practice. 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.

In case of patients, if the institutional protocol sets repositioning with a frequency of less than 4 hours, measurements will be made to the maximum that is set in each protocol. Otherwise, the maximum time for each position will be 4 hours.

Measuring instruments:

Pressure measurements will be made with the XSENSOR PX100: 64.160.02 (31.2 x 203.2 cm) pressure sensor, with 12.7 mm of space resolution of, which has 10,240 measuring points. The pressure sensor is composed with two perpendicularly oriented networks of parallel conductive strips, which are separated by a fine compressible elastomer. The intersection of two strips forms a capacitive node, determined by the surface of intersection of the two strips, and the distance separation between them, and with the elastomer. When pressure is applied to the node, the elastomer is compressed, the bands approach and capacity increases. This change in capacitance is correlated with pressure through a calibration process. The pressure range that is able to detect varies between 0.2 to 3.87 psi.

Tissue perfusion, oxygenation and temperature of the assessed area will be made with the system Periflux 5000, composed of 2 units of Laser Doppler Flowmetry (LDF): PeriFlux 5001, which includes the laser source; and PeriFlux 5002, which provides temperature and tissue oxygenation measurements. The information of both instruments will be collected and integrated into a software that allows the simultaneous measurement of all signals. Tissue oxygenation will be measured by transcutaneous oximetry (TcpO2), a noninvasive procedure that reflects the amount of oxygen diffuses into the capillaries through the epidermis. This process depends on the state of respiratory oxygenation, the oxygen carrying capacity of blood and the overall circulatory condition. Any deterioration in any of these three members, immediately affect the skin tissue perfusion, which allows to evaluate how these factors affect the PU risk. It is measured by an electrode that heats the underlying tissue to create a local hyperemia that intensifies blood perfusion and, consecuently, oxygen pressure increases. The heat dissolves the lipid structure of the keratinized layers of the epidermis, allowing the skin permeability to gas diffusion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pressure Ulcer
Intervention  ICMJE
  • Device: tcpO2
    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
Study Arms  ICMJE 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.
Interventions:
  • Device: tcpO2
  • Device: Laser Doppler
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 7, 2016)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Phase 1:

  • Inclusion criteria:

    • Healthy volunteers, between 20 to 65 years old, both female and male participants are being studied
    • With no cardiovascular, neurological, digestive, endocrine, renal, gynecological, respiratory, hematologic, infectious, dermatological, autoimmune or diagnosed musculoskeletal disease or functional limitations,
    • With tissue integrity and BMI between 18.5 to 25.9 kg/cm2 without scars in the sacred, back-lumbar, trochanteric, heels, elbows and shoulder blades areas.
  • Exclusion criteria:

    • The usual consumption for any reason of alpha-beta-blocking agents, or alpha-beta agonists,
    • Or directly or indirectly vasodilator-vasoconstrictor action drugs of any kind, •Anticoagulants,
    • Topical or systemic steroids,
    • Presence of pacemakers or implantable defibrillator,
    • Smoking,
    • High consumption of alcohol (>20g/week),
    • Presence of tattoos in the areas of measurement,
    • Lower limb amputation

Phase 2:

  • Inclusion criteria:

    • Patients (both female and male), between 18 to 85 years old, admitted to acute hospitalization, with risk of skin integrity deterioration assessed by Braden scale (punctuation lower than 16)
    • Without pressure ulcers,
    • Who agree to participate in the study.
  • Exclusion criteria:

    • Presence infusion of vasoactive drugs at the time of the study (dopamine, epinephrine, norepinephrine, dobutamine, nitroprusside, nitroglycerin, calcium channel blockers, ACE inhibitors).
    • Regular oral treatment of alpha and beta-blockers
    • And/or agonists or calcium channel blockers, Nitrates, ACE inhibitors, Angiotensin, Renin inhibitors, Diuretics, SSRIs, NSAIDs, will be accepted.
    • Also patients with pacemakers and/or implanted defibrillator,
    • Fever,
    • Anemia with Hb <10g/dl,
    • Hypotension with systolic blood pressure <80 mmHg,
    • Presence of transfusions in the past 4 weeks,
    • Consumption and derivatives of erythropoietin, iron supplements,
    • Oral or parenteral anticoagulants will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02736838
Other Study ID Numbers  ICMJE PI15/02016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party JOSE MIGUEL MORALES ASENCIO, University of Malaga
Study Sponsor  ICMJE University of Malaga
Collaborators  ICMJE Health Service of Andalucia
Investigators  ICMJE
Principal Investigator: Silvia García-Mayor, PhD Faculty of Health Sciences, University of Málaga, Spain
PRS Account University of Malaga
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP