Peripheral Perfusion and Oxygenation in Areas of Risk of Skin Integrity Impairment Exposed to Pressure Patterns.

NCT02736838 | Unknown

• 1 other identifier: PI15/02016
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pressure Ulcer

Keywords

Pressure; Pressure Ulcer; Skin perfusion; Skin oxygenation

Outcome Measures

Primary Outcomes (1)

• Peripheral tissue oxygenation (transcutaneous oxygen)

  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.

  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

Secondary Outcomes (1)

• Microvascular flow in peripheral tissues

  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

Study Arms (1)

Phase I

EXPERIMENTAL

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; Device: Laser Doppler

Interventions

tcpO2 DEVICE

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.

Phase I

Laser Doppler DEVICE

Phase I

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• University of Malaga: lead
• Health Service of Andalucia: collaborator

Related Publications (15)

• Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, Farrin A, Brown J, Schoonhoven L, Nixon J. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013 Jul;50(7):974-1003. doi: 10.1016/j.ijnurstu.2012.11.019. Epub 2013 Feb 1.

  PMID: 23375662 BACKGROUND

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  PMID: 24684197 BACKGROUND

• Stekelenburg A, Strijkers GJ, Parusel H, Bader DL, Nicolay K, Oomens CW. Role of ischemia and deformation in the onset of compression-induced deep tissue injury: MRI-based studies in a rat model. J Appl Physiol (1985). 2007 May;102(5):2002-11. doi: 10.1152/japplphysiol.01115.2006. Epub 2007 Jan 25.

  PMID: 17255369 BACKGROUND

• Moore ZE, Cowman S. Repositioning for treating pressure ulcers. Cochrane Database Syst Rev. 2015 Jan 5;1(1):CD006898. doi: 10.1002/14651858.CD006898.pub4.

  PMID: 25561248 BACKGROUND

• Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev. 2014 Apr 3;2014(4):CD009958. doi: 10.1002/14651858.CD009958.pub2.

  PMID: 24700291 BACKGROUND

• Chou R, Dana T, Bougatsos C, Blazina I, Starmer AJ, Reitel K, Buckley DI. Pressure ulcer risk assessment and prevention: a systematic comparative effectiveness review. Ann Intern Med. 2013 Jul 2;159(1):28-38. doi: 10.7326/0003-4819-159-1-201307020-00006.

  PMID: 23817702 BACKGROUND

• Nakagami G, Sanada H, Iizaka S, Kadono T, Higashino T, Koyanagi H, Haga N. Predicting delayed pressure ulcer healing using thermography: a prospective cohort study. J Wound Care. 2010 Nov;19(11):465-6, 468, 470 passim. doi: 10.12968/jowc.2010.19.11.79695.

  PMID: 21135794 BACKGROUND

• Farid KJ, Winkelman C, Rizkala A, Jones K. Using temperature of pressure-related intact discolored areas of skin to detect deep tissue injury: an observational, retrospective, correlational study. Ostomy Wound Manage. 2012 Aug;58(8):20-31.

  PMID: 22879313 BACKGROUND

• Kokate JY, Leland KJ, Held AM, Hansen GL, Kveen GL, Johnson BA, Wilke MS, Sparrow EM, Iaizzo PA. Temperature-modulated pressure ulcers: a porcine model. Arch Phys Med Rehabil. 1995 Jul;76(7):666-73. doi: 10.1016/s0003-9993(95)80637-7.

  PMID: 7605187 BACKGROUND

• Behrendt R, Ghaznavi AM, Mahan M, Craft S, Siddiqui A. Continuous bedside pressure mapping and rates of hospital-associated pressure ulcers in a medical intensive care unit. Am J Crit Care. 2014 Mar;23(2):127-33. doi: 10.4037/ajcc2014192.

  PMID: 24585161 BACKGROUND

• Swisher SL, Lin MC, Liao A, Leeflang EJ, Khan Y, Pavinatto FJ, Mann K, Naujokas A, Young D, Roy S, Harrison MR, Arias AC, Subramanian V, Maharbiz MM. Impedance sensing device enables early detection of pressure ulcers in vivo. Nat Commun. 2015 Mar 17;6:6575. doi: 10.1038/ncomms7575.

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• Kallman U, Engstrom M, Bergstrand S, Ek AC, Fredrikson M, Lindberg LG, Lindgren M. The effects of different lying positions on interface pressure, skin temperature, and tissue blood flow in nursing home residents. Biol Res Nurs. 2015 Mar;17(2):142-51. doi: 10.1177/1099800414540515. Epub 2014 Jul 18.

  PMID: 25037449 BACKGROUND

• Gomez-Gonzalez AJ, Morilla-Herrera JC, Lupianez-Perez I, Morales-Asencio JM, Garcia-Mayor S, Leon-Campos A, Marfil-Gomez R, Aranda-Gallardo M, Moya-Suarez AB, Kaknani-Uttumchandani S. Perfusion, tissue oxygenation and peripheral temperature in the skin of heels of healthy participants exposed to pressure: a quasi-experimental study. J Adv Nurs. 2020 Feb;76(2):654-663. doi: 10.1111/jan.14250. Epub 2019 Nov 20.

  PMID: 31651050 DERIVED

• Garcia-Mayor S, Morilla-Herrera JC, Lupianez-Perez I, Kaknani Uttumchandani S, Leon Campos A, Aranda-Gallardo M, Moya-Suarez AB, Morales-Asencio JM. Peripheral perfusion and oxygenation in areas of risk of skin integrity impairment exposed to pressure patterns. A phase I trial (POTER Study). J Adv Nurs. 2018 Feb;74(2):465-471. doi: 10.1111/jan.13414. Epub 2017 Sep 15.

  PMID: 28792613 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Laser-Doppler Flowmetry

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques

Study Officials

• Silvia García-Mayor, PhD

  Faculty of Health Sciences, University of Málaga, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: April 13, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share