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临床试验/NCT00910286
NCT00910286已完成不适用

VENTILAÇÃO MECÂNICA COM PRESSÃO SUPORTE: ESTUDO DA ASSINCRONIA EXPIRATÓRIA (in Portughese)

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2004年12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
已完成
入组人数
18
试验地点
1
主要终点
comfort

研究概览

简要总结

Objective: To compare termination criteria (TC) of pressure support ventilation (PSV).

Design: Randomized cross-over clinical trial.

Setting: Intensive Care Units.

Patients: Sixteen patients on PSV with ability to answer a visual analog scale (VAS).

Protocol and Measurements: Each patient was ventilated with two different TC ventilators, fixed and automatic, with measurements of ventilatory mechanic variables, breathing comfort and asynchrony patterns.

详细描述

Two ventilators with different flow termination criteria (TC) were compared: Servo 300 (Siemens-Elema, Solna, Sweden) with fixed TC (5% of peak inspiratory flow) and Newport E500 (Newport Medical Instruments, Costa Mesa, CA) with automatic TC (varies between 5% to 55%). Each patient remained three hours in the protocol, one hour in each ventilator, after been randomized to one of two sequences of 3 steps: Fixed 5% / Automatic / Fixed 5% or Automatic / Fixed 5% / Automatic (Figure 1). The transition among the ventilators was realized through a three-way flow directional valve (Three-Way T-Shape TM, Hans Rudolph Incorporation, Kansas City, EUA).

The PS level was determined by clinical staff to partially unload the respiratory muscle without respiratory distress based on observation of the patient's breathing pattern. The PS, the positive end expiratory pressure (PEEP), the inspiratory oxygen fraction (FiO2) and the pressure trigger sensitivity levels were unchanged during the protocol.

Study variables: Patients' demographic, anthropometric and clinical data were obtained (Table 1).

The study variables were detected noninvasively using only airway pressure (Paw) and flow signals, obtained with a pressure differential pneumotachometer (CO2SMO Plus; Novametrix Medical Systems, Wallingford, CT) located at the distal end of the ventilator circuit . Three records of five minutes were realized in each study step: time = 0' (0-5 min), t = 30' (30-35 min) and t = 55' (55-60 min). Data were digitalized at 100 Hz and recorded on a personal computer for subsequent analysis (LabVIEW 7.1, National Instruments Corporation, Austin, TX). A total of nine record phases of five minutes from each patient were analyzed .The variables values were obtained by one hundred ventilatory cycles from each recorded phase

Measured variables:

研究设计

研究类型
Interventional
干预模型
Crossover
盲法
Single (Participant)

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 under PSV for more than 24 hours,
  • Age > 18 years
  • Ability to answer to a symptom visual analog scale (VAS)

排除标准

  • Hemodynamic instability (use of vasoactive drugs like dopamine, dobutamine or norepinephrine)
  • Bronchopleural fistula

研究组 & 干预措施

VENTILATOR WEANING

Other

Two ventilators with different flow termination criteria (TC) were compared: Servo 300 (Siemens-Elema, Sweden) with fixed TC (5% of peak inspiratory flow) and Newport E500 (Newport Medical Instruments, CA) with automatic TC (varies between 5% to 55%). Each patient remained three hours in the protocol, one hour in each ventilator, after been randomized to one of two sequences of 3 steps: Fixed 5% / Automatic / Fixed 5% or Automatic / Fixed 5% / Automatic . The PS, the positive end expiratory pressure (PEEP), the inspiratory oxygen fraction (FiO2) and the pressure trigger sensitivity levels were unchanged during the protocol.

干预措施: Pulmonary Ventilator (Other)

结局指标

主要结局

comfort

时间窗: 30 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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