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临床试验/NCT02801994
NCT02801994已完成不适用

Impact of Proportional Assisted Ventilation on Dyspnea and Asynchrony in Mechanically Ventilated Patients

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Quantification of dyspnea

研究概览

简要总结

Rational. The mismatch between the activity of the respiratory muscles and the assistance delivered by the ventilator results in patient-ventilator disharmony, which is commonly observed in ICU patients and is associated with dyspnea and patient-ventilator asynchrony. Both dyspnea and asynchrony are in turn associated with a worse prognosis. Unlike conventional modes of mechanical ventilation, such as pressure support ventilation (PSV) that deliver a constant level of assistance regardless of the patient effort, Proportional Assisted Ventilation (PAV) adjusts the level of ventilator assistance to the activity of respiratory muscles. To date, data on the impact of PAV on dyspnea and patient ventilator asynchrony are scarce and most studies have been conducted in healthy subjects or in ICU patients who had no severe dyspnea nor severe asynchrony. To our knowledge, there are no data in patients with severe patient-ventilator dysharmony.

Study Aim. To evaluate the impact of PAV on dyspnea and patient-ventilator asynchrony in ICU mechanically ventilated patients in intensive care with severe patient-ventilator disharmony defined as either severe dyspnea or severe patient-ventilator asynchrony.

Patients and Methods. Will be included 24 ICU mechanically ventilated patient exhibiting severe patient-ventilator dysharmony with PSV. The intensity of dyspnea will be assessed by the VAS, the ICRDOSS and by the electromyogram of extradiaphragmatic inspiratory muscles and pre inspiratory potential collected from the electroencephalogram. The prevalence of patient-ventilator asynchrony will be quantified.

Expected results. It is anticipated that the switch from PSV to PAV will decrease the prevalence and severity of dyspnea and the prevalence of patient-ventilator asynchrony.

详细描述

Rational As opposed to controlled mechanical ventilation, partial modes of assisted ventilation maintains a certain level spontaneous activity of respiratory muscles. As a consequence, assisted ventilation may contribute to prevents ventilator induced diaphragm dysfunction (1-3), improves gas exchanges (4), reduces the use of sedative agents, which can ultimately shorten weaning from mechanical ventilation (5).

The most widely used partial ventilatory assistance mode is pressure support ventilation (PSV) (6), in which a constant preset level of pressure assists each inspiration regardless of the patient's inspiratory effort. Mismatching between patient demand and level of assistance, which the investigators will term patient-ventilator dysharmony in the present project is therefore possible and can be potentially harmful. On the one hand, underassistance may induce respiratory discomfort and dyspnea (7), which is an immediate cause of suffering, generates anxiety and is a source of delayed neuropsychological sequelae such as dark respiratory recollections and post-traumatic stress disorders(8-12). One the other hand, overassistance may cause lung overdistension and volutrauma (13). Finally, both underassistance and overassistance may generate patient-ventilator asynchrony that is associated with poorer clinical outcomes (14). Of notice, underassistance is likely to be associated with an asynchrony named double-triggering while over assistance is more commonly associated with ineffective efforts(15).

Proportional modes of mechanical ventilation have been designed to overcome this weakness of (PSV). Indeed, as opposed to PSV that delivers a constant level of assistance regardless of the patient inspiratory effort, proportional modes of ventilation adjust the amount of assistance delivered with respect to the patient's efforts. Proportional Assisted Ventilation (PAV) is one of these modes and adjusts ventilator assistance to the activity of respiratory muscles estimated by an algorithm (16-23). Previous studies have shown the potential benefits of PAV to prevent the risk of overassistance(24) and in turn to reduce the prevalence of ineffective effort (25-28). In addition, PAV increases the variability of the breathing pattern (17, 20-23, 29-32). To date, data on the impact of PAV on dyspnea and patient ventilator asynchrony are scarce (24-28, 33). Most of these works have been conducted in healthy subjects or in ICU patients with no severe dyspnea nor severe asynchrony (24-28, 33). To our knowledge, there are no data in patients with severe patient-ventilator dysharmony.

Because PAV adjusts the level of assistance to the activity of respiratory muscles, a surrogate of the respiratory drive, it is licit to hypothesize that PAV should prevent severe patient-ventilator dysharmony, defined as either severe dyspnea or severe patient-ventilator asynchrony.

The objective of the present research proposal is to evaluate the impact of PAV on dyspnea and patient-ventilator asynchrony in ICU mechanically ventilated patients in intensive care with severe patient-ventilator disharmony defined as either severe dyspnea or severe patient-ventilator asynchrony.

研究设计

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

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

  • Patients will be included as soon as the meet the following criteria.
  • Intubation and mechanical ventilation for a respiratory cause with severe hypoxemia defined as a PaO2 to FiO2 ratio <300 recorded at least once during the present ICU stay.
  • PSV ventilation for > 6 hours.
  • Severe patient-ventilator disharmony defined by either
  • a dyspnea ≥ 4 on a visual analogic scale (VAS) from 0 to 10 with respiratory rate ≥ 24 /minute and a drawing of neck muscles,
  • or by an asynchrony index (IA) ≥ 10%, defined as = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100
  • No improvement of disharmony despite an optimization of ventilator setting defined as follows.
  • No improvement of dyspnea or double triggering despite an increase of the level of pressure support that should not generate a tidal volume > 10 ml/kg
  • No improvement of ineffective efforts despite a decrease of the level of pressure support or generation of a dyspnea (defined as VAS>4) in response of the decrease of the level of pressure support.
  • Decision of the physician in charge of the patient to switch mechanical ventilation from PSV mode to PAV.
  • Remaining duration of mechanical ventilation estimated ≥ 24 hours.
  • Patient able to communicate (Richmond Agitation and Sedation Scale between -1 and +1).

排除标准

  • Exclusion criteria will be as follows.
  • Severe hypoxemia defined as a PaO2 to FiO2 ratio <150 mmHg.
  • Delirium according to the CAM-ICU (1)
  • Hemodynamic instability defined by the need for intravenous fluids or catecholamine during the previous 24 hours.
  • Age <18 years; pregnant woman.

结局指标

主要结局

Quantification of dyspnea

时间窗: in real time, during the procedure

Dyspnea will be quantified with with the ICU Respiratory Distress Operating Scale (IC-RDOS)

次要结局

  • Airway pressure(in real time, during the procedure)
  • Quantification of dyspnea(in real time, during the procedure)
  • Electromyography (EMG) of extra inspiratory diaphragmatic muscles(in real time, during the procedure)
  • Patient-ventilator asynchrony(in real time, during the procedure)
  • Flow(in real time, during the procedure)
  • Electroencephalogram (EEG) in search of a pre-inspiratory potential(in real time, during the procedure)
  • Arterial blood gas(in real time, during the procedure)

研究者

发起方
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
申办方类型
Other
责任方
Sponsor

研究点 (2)

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