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临床试验/NCT06536231
NCT06536231招募中不适用

Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Maximal change in cardiac index during RIC procedure

研究概览

简要总结

The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and after the RIC intervention.

详细描述

The investigators hypothesized that the inflation of the blood pressure cuff during the remote ischemic conditioning (RIC) procedure would lead to an increase in stroke volume (SV), cardiac index (CI), and peripheral perfusion index and that these changes would correlate with the hemodynamic changes induced by passive leg raising (PLR).

Furthermore, the clinical relevance of the RIC effect in critically ill patients, particularly in terms of determining their hemodynamic responsiveness, remains uncertain. The investigators hypothesized that the RIC procedure influences hemodynamic changes during PLR.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged over 18 years,
  • •admitted to the intensive care unit,
  • •monitored with a transpulmonary thermodilution device with calibrated pulse contour analysis (Pulsion Medical Systems, Munich, Germany),
  • •decision by the physician in charge to perform passive leg raising.

排除标准

  • •pregnancy,
  • •advanced malignancy,
  • •peripheral artery disease affecting both arms,
  • •head trauma,
  • •deep vein thrombosis in the lower limbs,
  • •intra-abdominal hypertension, defined as an intra-abdominal pressure greater than 12 mmHg.

研究组 & 干预措施

Passive leg raising and Remote ischemic conditioning

Experimental

Supine position was followed by the passive leg raising (PLR) maneuver. After completing the PLR test, participants were placed in the supine position for 5 min. Thereafter, remote ischemic conditioning (RIC) was performed. After the RIC procedure, the patient is left in supine position for 5 minutes. Then the PLR test was repeated, after which the participants were placed in a supine position for another 5 min at rest. When the patient fluid responder, physician in charge may decide to perform a fluid infusion (500 mL of crystaloids). The PLR test can also be performed to make decision for fluid removal. This decision is triggered by a negative PLR test in the later phase of ICU treatment. If the physician has decided to administer a fluids, systemic hemodynamics and peripheral perfusion index are measured immediately after completion of the fluid infusion.

干预措施: Remote ischemic conditioning (Procedure)

结局指标

主要结局

Maximal change in cardiac index during RIC procedure

时间窗: During RIC procedure

Change in this parameter is determined during each inflation and release of the blood pressure cuff.

Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure

时间窗: During RIC procedure

Change in this parameter is determined during each inflation and release of the blood pressure cuff.

Maximal change in peripheral perfusion index during RIC procedure

时间窗: During RIC procedure

Change in this parameter is determined during each inflation and release of the blood pressure cuff. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.

The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during the RIC procedure and those observed during passive leg raising (PLR).

时间窗: During RIC procedure, as well as during passive leg raising.

The maximum changes in these parameters, as determined by the RIC procedure and PLR, were identified, and their correlation was subsequently calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.

The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during PLR before the RIC procedure and those observed during PLR after the RIC procedure.

时间窗: During PLR both before and after the RIC procedure.

The maximum changes in these parameters, as measured during PLR before and after the RIC procedure, were identified. Subsequently, the correlation between these changes was calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.

次要结局

  • The correlation between the maximum perfusion index (PI), the time to reach maximum PI during cuff release and the maximal changes in stroke volume index, cardiac index and perfusion index observed during PLR.(During RIC procedure, as well as during PLR.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrius Pranskunas

prof.

Lithuanian University of Health Sciences

研究点 (1)

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