Influence of RIC on the Orthostatic Competence of the Microcirculation

August 10, 2023 updated by: Peter Paul Pfeiler, MD, ISAR Klinikum

Pilot Study: Influence of Ischemic Preconditioning on the Orthostatic Competence of the Microcirculation in the Lower Extremity

The goal of this clinical trial (pilot study) is to learn about the microcirculatory regulation of the lower extremity under orthostatic stress with and without RIC - Remote Ischemic Preconditioning in healthy participants. The main question it aims to answer are:

Do the beneficial effects of RIC withstand orthostatic stress? / Does RIC benefit lower extremity microcirculation in ortho-statically stressed subjects? Is there a relationship/correlation between the variables of microcirculation and hemodynamics in the context of RIC and orthostatic loading?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The use of free flaps is a standard procedure in reconstructive plastic surgery, in which a wide variety of tissue units are microsurgically transplanted, often to cover defects on the body surface. Microvascular tissue transplants depend on an adequate blood supply, which is particularly vulnerable in the first postoperative phase. In the case of reconstructions of the lower extremities in particular, the flap perfusion is stressed during the first mobilizations due to the orthostatic load. For this reason, the mobilization of the patients is gradually increased from day to day with precise monitoring of the blood flow (so-called flap training).

A procedure for temporarily improving the blood flow in free flaps is ischemic preconditioning (RIC - Remote Ischemic Preconditioning). Repeated, short cycles of ischemia/reperfusion applied to a circumscribed vascular territory (e.g. supra systolic tourniquet arm) lead to an increase in tissue perfusion, even outside the area of application (arm).

RIC could have the potential to optimize the tissue perfusion of flaps even under orthostatic stress and to promote an earlier mobilization of patients. Our work investigates the influence of RIC on orthostatic competence (as part of a standardized orthostatic load with a tilting table) of the microcirculatory system in the lower extremities and the orthostatic hemodynamic regulation itself.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80331
        • ISAR Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Non-smokers
  • No diseases relevant to circulation and blood flow (arterial hypertension, peripheral arterial occlusive disease, chronic venous insufficiency)
  • Subjects must be capable of insight. Anyone who can understand the nature, significance, and scope of the clinical trial and determine their will accordingly is capable of insight.

Exclusion Criteria:

  • Non-consent
  • Lack of compliance
  • Syncope tendency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tilting table without and with RIC
The experimental setup consists of two separate measurements. In the first measurement, the subject is ortho-statically stressed by changing the position (lying to upright) on a tilting table (similar to the established tilting table test). 24 hours after the first measurement, the ischemic preconditioning will be carried out in three cycles with a directly subsequent tilting table test.
Procedure: Remote ischemic preconditioning
The empty tourniquet (VBM Tourniquet Touch®, Sulz a.N. Germany) is attached to the right upper arm. The measurement starts from this point in time. After lying flat for 10 minutes, the upper arm tourniquet is inflated to 250 mmHg. In all subjects, the ischemia was verified by palpation and Doppler signal of the radial artery. The ischemia phase is carried out for 10 minutes, so the tourniquet is opened and a 10-minute reperfusion phase is started, followed by a total of 3 cycles. After the 3rd ischemia phase, the tilting table test is followed by a 15-minute lying interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microcirculation parameters
Time Frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative blood flow in arbitrary units [AU]
continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microcirculation parameters - oxygen saturation
Time Frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) capillary venous oxygen saturation in percent (%)
continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Microcirculation parameters - Relative amount of hemoglobin
Time Frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative amount of hemoglobin in arbitrary units [AU]
continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Hemodynamics
Time Frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
hemodynamics parameters: systolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Hemodynamics
Time Frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
hemodynamics parameters: mean arterial blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Hemodynamics
Time Frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
hemodynamics parameters: diastolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Hemodynamics
Time Frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
hemodynamics parameters: heart rate in beats per minute (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ISAR Klinikum

Investigators

  • Study Chair: Ulf Dornseifer, MD, PhD, Department Plastic Surgery ISAR Klinikum, Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2023

Primary Completion (Estimated)

August 10, 2023

Study Completion (Estimated)

August 13, 2023

Study Registration Dates

First Submitted

July 30, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIC-KIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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