NCT05990907

Influence of RIC on the Orthostatic Competence of the Microcirculation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ISAR Klinikum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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?

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.

Conditions

• Microcirculation
• Orthostatic Intolerance
• Remote Ischemic Preconditioning
• Hemodynamics

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-30
• Primary completion: 2023-08-10
• Completion: 2023-08-13
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: Germany