Influence of RIC on the Orthostatic Competence of the Microcirculation

ISAR Klinikum

Status: Active, not recruiting

Conditions: Orthostatic Intolerance; Remote Ischemic Preconditioning; Microcirculation; Hemodynamics

Treatments: Procedure: Remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05990907

RIC-KIP

Details and patient eligibility

About

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?

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Tilting table without and with RIC

Other group

Description:

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.

Treatment:

Procedure: Remote ischemic preconditioning