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临床试验/NCT03413657
NCT03413657已完成不适用

Predicting Fluid Responsiveness Using Transiently Increased Intrathoracic Pressure in Mechanically Ventilated Patients

University of California, Davis2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Pulse Pressure Variation

研究概览

简要总结

The goal of this study is to identify in patients requiring active fluid resuscitation and mechanical ventilation for circulatory shock, can a controlled increase in intrathoracic pressure (either by positive-end expiratory pressure (PEEP) or tidal volume (TV)) predict responsiveness to additional fluid resuscitation.

We hypothesize that a temporary, physiologically-safe increase in positive-end expiratory pressure (PEEP) and/or a temporary increase in tidal volume (from 6 cc/kg predicted body weight (PBW) to 8 cc/kg PBW) in patients requiring invasive mechanical ventilation will predict fluid responsiveness based upon an assessment of the change in pulse pressure and stroke volume variation.

详细描述

Once an eligible subject is identified and written or telephone consent is obtained from the patient or surrogate as appropriate, we will record demographic data and clinical information including age, sex, height, actual body weight, predicted body weight (PBW), APACHE II on admission, primary diagnosis, reason for ICU admission, and dose of vasopressors.

Patients will be intubated and on assist-control volume ventilation receiving low tidal volumes. Sedation will be titrated per current MICU protocol to minimize patient discomfort and minimizing ventilator dyssynchrony. In keeping with standard practice, the dose of vasoactive medications will be kept constant during the intervention period. The standard practice is to titrate vasopressor therapy every five minutes, so keeping vasoactive medications constant for sixty seconds is in keeping with the standard of care. All subjects will be in an ICU setting and monitored per standard of care (vital signs, telemetry, ventilator data) by a respiratory therapist, pulmonary and critical care fellow or faculty member, and critical care nurse at the bedside throughout the entire intervention.

A point of care (POC) echocardiogram will be performed by the investigator performing the intervention in order to measure the stroke volume index (surrogate for cardiac output).

Subjects will be randomized to either undergo the PEEP challenge or tidal volume challenge first. After the initial challenge, subjects will cross over to whichever challenge has not yet been performed.

The simple changes to the ventilator we are proposing to use as challenges in this study are done frequently and routinely in the ICU with or without the supervision of a physician, but we will have a physician present throughout the entire proposed intervention. For the subjects undergoing PEEP challenge first, we will do the following:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Mechanically ventilated
  • Identified by treatment team as requiring intravenous fluid bolus
  • Acute circulatory failure during admission (systolic blood pressure (SBP) ≤90 mmHg or mean arterial pressure (MAP) ≤70 mmHg or requiring vasopressors to maintain SBP >90 mmHg or MAP >70 mmHg, along with one or more of the following:
  • urinary flow ≤0.5 mL/kg/min for ≥2 hours,
  • heart rate ≥100 beats per minute
  • presence of skin mottling
  • blood lactate concentration ≥4 mmol/L

排除标准

  • Contraindication to fluid bolus
  • Assynchrony Index > 10%
  • Clinically significant cardiac arrhythmia
  • Severe valvular heart disease
  • Chest tubes with air leak
  • Abdominal compartment syndrome
  • Pregnancy
  • Concurrent nebulized medication or inhaled nitric oxide
  • Transthoracic echogenicity unsuitable for measuring velocity-time integral of aortic blood flow (SVI)
  • Clinical brain death
  • PEEP > 15 cmH2O

结局指标

主要结局

Pulse Pressure Variation

时间窗: Following 60 seconds of intrathoracic pressure challenge

Temporary increase in intrathoracic pressure (PEEP or TV) will predict fluid responsiveness using an absolute increase in pulse pressure variation by 3% or more.

次要结局

  • Mortality(7 days)
  • Stroke Volume Variation(Following 60 seconds of intrathoracic pressure challenge)
  • End-tidal carbon dioxide(Following 60 seconds of intrathoracic pressure challenge)
  • Heart Rate(Following 60 seconds of intrathoracic pressure challenge)
  • Mean Arterial Pressure(Following 60 seconds of intrathoracic pressure challenge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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