Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns. (POTER-DIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: tcpO2 Device: Laser Doppler Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
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.
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Malaga
Health Service of Andalucia
Investigators
Layout table for investigator information
Principal Investigator: Silvia García-Mayor, PhD Faculty of Health Sciences, University of Málaga, Spain

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: JOSE MIGUEL MORALES ASENCIO, PhD, University of Malaga
ClinicalTrials.gov Identifier: NCT02736838     History of Changes
Other Study ID Numbers: PI15/02016
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by JOSE MIGUEL MORALES ASENCIO, University of Malaga:
Pressure
Pressure Ulcer
Skin perfusion
Skin oxygenation
Additional relevant MeSH terms:
Layout table for MeSH terms
Pressure Ulcer
Skin Ulcer
Skin Diseases