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临床试验/NCT02918526
NCT02918526Unknown不适用

Hemodynamic Study With Pressure Recording Analytical Method (PRAM) of the Cardiovascular Response to the Positioning of the Extraglottic Device in Gynecological Surgery

Azienda Ospedaliero-Universitaria Careggi0 个研究点目标入组 94 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
94
主要终点
Cardiac Index (L/min/m2)

研究概览

简要总结

The purpose of the study will be to record the hemodynamic response measured by traditional methods (non-invasive blood pressure and ECG) and Pressure Recording Analytical Method in patients undergoing laryngeal mask placement compared with the hemodynamic response measured in patients undergoing laryngoscopy and tracheal intubation for performing surgery in gynecological area and assess the differences with the two methods.

详细描述

Introduction Laryngoscopy and tracheal intubation may cause significant hemodynamic changes in the patient and induce cardiovascular complications.

Numerous studies have sought methods to reduce this risk (1-5). The extraglottic not involving either laryngoscopy or their passage through the vocal cords, have proven protective of the possible cardiovascular complications resulting from the placement of respiratory prosthesis (6,7).

Measurements of hemodynamic changes resulting from the procedures for airway management with extraglottic have not previously been carried out.

The MostCare (Vytech, Vygon Italia srl, Padova, Italy) is a monitor provided for more than 10 years at the obstetric gynecological anesthesia unit able to evaluate the hemodynamic changes in a patient based on the Pressure Recording Analytical Method (PRAM).

This is a measurement method of the cardio-circulatory performance of a patient that does not require calibration and / or insertion of a pre-estimated data because the method of analysis of the wave form of the arterial pressure is developed completely a priori (8). The measurement derives from the simultaneous analysis of the components of a pulsatile flow and the continuous flow as a ratio between the area under the curve of the pulsatile portion of the systolic pressure and the characteristic impedance Z (t). The PRAM method has proven effective in many clinical settings (9).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients scheduled for elective gynecological surgery under general anesthesia
  • •Age >18 <50 years
  • •Presence of informed consent in the clinical record
  • •Belonging to risk classes ASA 1 - ASA 2

排除标准

  • •Hypertension
  • •Heart failure
  • •Treatment with beta blockers, Ca channel blockers, antihypertensives, vagolytic
  • •Hypo/hyperthyroidism and its treatment
  • •Adrenal insufficiency and its treatment
  • •Autonomic neuropathy

研究组 & 干预措施

Laryngeal Mask

Experimental

laryngeal mask (LMA)

干预措施: airway management (Device)

Oro Tracheal Intubation

Active Comparator

oro tracheal intubation

干预措施: airway management (Device)

结局指标

主要结局

Cardiac Index (L/min/m2)

时间窗: for 5 minutes after induction of anesthesia

Cardiac Index (L/min/m2) measured with Pulse Recording Analytic Method

次要结局

  • Blood pressure (mmHg)(for 5 minutes after induction of anesthesia)
  • Stroke Volume Index (SVI) (ml/beat /m2)(for 5 minutes after induction of anesthesia)
  • Heart rate (bpm)(for 5 minutes after induction of anesthesia)
  • Cardiac Cycle Efficiency (CCE) (a dimensional value)(for 5 minutes after induction of anesthesia)
  • Stroke Volume (SV) (ml/beat)(for 5 minutes after induction of anesthesia)
  • Cardiac Output (CO) (L/min)(for 5 minutes after induction of anesthesia)
  • Systemic Vascular Resistance (SVR) (dynes•s /cm5)(for 5 minutes after induction of anesthesia)
  • Cardiac Power Output (CPO) (W).(for 5 minutes after induction of anesthesia)

研究者

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

Alessandro Di Filippo

Medical Doctor

Azienda Ospedaliero-Universitaria Careggi

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