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Influence of RIC on the Orthostatic Competence of the Microcirculation

Primary Purpose

Microcirculation, Orthostatic Intolerance, Remote Ischemic Preconditioning

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sponsored by
ISAR Klinikum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Microcirculation focused on measuring Microcirculation, Remote ischemic preconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • ISAR Klinikum

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tilting table without and with RIC

Arm 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.

Outcomes

Primary Outcome Measures

Microcirculation parameters
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative blood flow in arbitrary units [AU]

Secondary Outcome Measures

Microcirculation parameters - oxygen saturation
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) capillary venous oxygen saturation in percent (%)
Microcirculation parameters - Relative amount of hemoglobin
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative amount of hemoglobin in arbitrary units [AU]
Hemodynamics
hemodynamics parameters: systolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
Hemodynamics
hemodynamics parameters: mean arterial blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
Hemodynamics
hemodynamics parameters: diastolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
Hemodynamics
hemodynamics parameters: heart rate in beats per minute (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)

Full Information

First Posted
July 30, 2023
Last Updated
August 10, 2023
Sponsor
ISAR Klinikum
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1. Study Identification

Unique Protocol Identification Number
NCT05990907
Brief Title
Influence of RIC on the Orthostatic Competence of the Microcirculation
Official Title
Pilot Study: Influence of Ischemic Preconditioning on the Orthostatic Competence of the Microcirculation in the Lower Extremity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2023 (Actual)
Primary Completion Date
August 10, 2023 (Anticipated)
Study Completion Date
August 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ISAR Klinikum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microcirculation, Orthostatic Intolerance, Remote Ischemic Preconditioning, Hemodynamics
Keywords
Microcirculation, Remote ischemic preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The research project is a controlled, single-arm, monocentric clinical study. Due to the study design, randomization and blinding are not possible. Unfortunately, there is no scientific data on how long the effects of ischemic preconditioning last. Thus, in a cross-over design study with protocols 1 and 2 in a different order, there would be a risk or bias that subjects who received ischemic preconditioning in the first measurement would have this effect in the second measurement. For this reason, we decided on a standardized procedure for measurement 1 (without ischemic preconditioning) and measurement 2 (with ischemic preconditioning). In this case, the study design would be one-armed.
Masking
None (Open Label)
Masking Description
Due to the study design, randomization and blinding are not possible.
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tilting table without and with RIC
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Microcirculation parameters
Description
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative blood flow in arbitrary units [AU]
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
Secondary Outcome Measure Information:
Title
Microcirculation parameters - oxygen saturation
Description
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) capillary venous oxygen saturation in percent (%)
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
Title
Microcirculation parameters - Relative amount of hemoglobin
Description
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative amount of hemoglobin in arbitrary units [AU]
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
Title
Hemodynamics
Description
hemodynamics parameters: systolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
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
Title
Hemodynamics
Description
hemodynamics parameters: mean arterial blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
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
Title
Hemodynamics
Description
hemodynamics parameters: diastolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
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
Title
Hemodynamics
Description
hemodynamics parameters: heart rate in beats per minute (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Dornseifer, MD, PhD
Organizational Affiliation
Department Plastic Surgery ISAR Klinikum, Munich
Official's Role
Study Chair
Facility Information:
Facility Name
ISAR Klinikum
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80331
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of RIC on the Orthostatic Competence of the Microcirculation

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