此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Evaluation of Fluid Responsiveness With Pulse Variation Index and Systolic Blood Pressure Changes After Lung Recruitment Maneuver

2021年7月31日 更新者:Ankara City Hospital Bilkent

The Relationship Between The Change in Systolic Blood Pressure and The Pleth Variability Index (PVI) After The Lung Recruitment Maneuver (LRM) to Evaluate Fluid Responsiveness in Open Abdominal Surgeries

Evaluation of Fluid Responsiveness With Pulse Variation Index and Systolic Blood Pressure Changes After Lung Recruitment Maneuver

研究概览

详细说明

After obtaining ethics committee approval, at least 84 patients who will undergo elective open abdominal surgery under general anesthesia in the operating room of the Ministry of Health Ankara City Hospital will be included in the study. The study is a single center, prospective, observational study.

Weight, height, age, gender, BMI (body mass index), ASA information of the patients will be recorded. Induction and anesthesia management will be applied in accordance with the standard working order of the anesthesia clinic. After the patient is taken to the operating table, non-invasive arterial blood pressure monitoring (noninvasive), 5-lead ECG and pulse oximetry, in addition to standard hemodynamic monitoring, Bispectral Index (BIS), temperature and Massimo ® pulse oximeter (Masimo Corp., Irvine, CA, USA). ) will be monitored. General anesthesia induction will be performed with 0.02 mg / kg midazolam, 1mg / kg lidocaine, 1mcg / kg fentanyl and 2mg / kg propofol after preoxygenation in accordance with the routine practice of the anesthesia clinic, and endotracheal intubation will be performed with a suitable tube for the patient to be provided with 0.6mg / kg rocuronium. BIS target value range will be determined as 40-60, and anesthesia maintenance will be provided by modifying the volatile anesthetic concentration and remifentanil infusion dose (0.1-1 mcg / kg / min) in accordance with hemodynamic values. Ventilation mode and ventilation parameters; tidal volume (6-8 ml / kg according to ideal body weight), respiratory rate (12-16) and end-tidal CO2 values in the range of 30-40 mmhg, inspiratory / expiratory ratio 1: 2, positive end expiratory pressure (PEEP) 5 cm H2O and FiO2: will be set as 50%. After the Allen test to be performed preoperatively, radial artery catheterization and invasive blood pressure monitoring of the non-dominant hand, a 7 fr three lumen central catheter will be placed into the right internal jugular vein with ultrasound (USG) and central venous pressure (CVP) monitoring will be performed. These applications are routinely performed in patients scheduled for open abdominal surgery in our clinic. Preferably 16G or 18G , 2 peripheral venous lines will be placed and fluid will not be given before fluid replacement. Measurements will begin after the patient preparation is complete, after a hemodynamically stable period (defined as the period in which the mean arterial blood pressure (MAP) change is <10% within 5 minutes), in the supine position, and when the patient is confirmed by a second observer that there is no spontaneous breathing effort. Hemodynamic parameters; heart rate (HR) (beats / minute), central venous pressure (CVP) (mmHg), systolic arterial blood pressure (SAP) (mmHg), diastolic arterial blood pressure (DAP) (mmHg), mean arterial blood pressure (MAP) ) (mmHg), peripheral oxygen saturation (SpO2), PVI and BIS baseline values (baseline 1) will be recorded. The LRM will be automatically adjusted in the mechanical ventilator to be at 30 cm H2O for 30 seconds, and the test will begin, all hemodynamic parameters, especially SAB and PVI, where the maximum change at the end of 30 seconds, will be recorded (after LRM), and the differences initial baseline values will be calculated and recorded as percentages. After the recording of the second values, the crystalloid infusion at 10 ml / kg will be made to the patient through the peripheral venous line within 15 minutes, 10 minutes after the end of the infusion, new baseline values will be taken before the test (baseline 2). After fluid replacement, LRM will be repeated in the same way. The values after LRM (Fluid Challenge-FC) will be recorded and differences between basal 2 values will be calculated and recorded as percentages. Primary measurement parameters are determined as PVI and SAB, and secondary measurement parameters are HR, DAB, OAB, SpO2, CVP and BIS. The research is terminated by calculating the percentage of PVI changes with SAB formed by LRM after fluid challenge.

研究类型

观察性的

注册 (预期的)

84

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Ankara、火鸡
        • 招聘中
        • Ankara City Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

patient who will undergo elective open abdominal surgery under general anesthesia in our hospital

描述

Inclusion Criteria:

  • ASA physical status 1 to 3 patients, over 18 years of age who will undergo elective open abdominal surgery under general anesthesia

Exclusion Criteria:

  • being over 75 years old, pregnant, who are contraindicated to use anesthetic drugs, BMI <18 and BMI> 40, who used inotropes or vasopressor drugs before or during the operation, with preoperative lung disease, with left ventricular ejection fraction less than 30%, with suspected right ventricular dysfunction (due to chronic obstructive pulmonary disease (COPD) or obstructive sleep apnea syndrome (OSAS)), with moderate to severe valvular disease, with hemodynamic instability in the perioperative period, with severe peripheral vascular occlusion, with liver failure, with renal insufficiency, with intracranial hypertension and with pulmonary hypertension.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
correlation between systolic blood pressure change after LRM and PVI in patients who will undergo elective open abdominal surgery under general anesthesia
大体时间:first 30 minutes of general anesthesia
In this study, the presence of a correlation between systolic blood pressure change after LRM and PVI in patients who will undergo elective open abdominal surgery under general anesthesia, the systolic pressure change in LRM is a non-invasive test that can be used to predict fluid responsiveness. We aim to reduce the invasive procedures required for the measurement of cardiac output used in the evaluation and to develop an alternative method to the use of expensive and not always accessible devices required for measurements.
first 30 minutes of general anesthesia

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Oya Kılcı, MD、Ankara City Hospital Bilkent

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月15日

初级完成 (实际的)

2021年7月1日

研究完成 (预期的)

2021年12月31日

研究注册日期

首次提交

2021年6月17日

首先提交符合 QC 标准的

2021年6月17日

首次发布 (实际的)

2021年6月25日

研究记录更新

最后更新发布 (实际的)

2021年8月3日

上次提交的符合 QC 标准的更新

2021年7月31日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • E2-21-468

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅