Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)
Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial
Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of lack of previous outcome data in such patients, all patients requiring RICU admission for acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.
The patients meeting the aforementioned criteria will randomly assigned to ventilation with assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence will be computer generated. The assignments will placed in sealed opaque envelopes and each patient's assignment was made on admission to the RICU by the attending physician. Blinding of treatment is not possible.
All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems, Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30 cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals11.These patients will be weaned as per standard protocol of spontaneous breathing trial of 30 minutes once they are recognized eligible as per statement of the sixth International consensus conference on weaning.
研究概览
详细说明
Inclusion criteria:
Study to include at least 40 patients admitted to RICU with diagnosis of ARDS as defined by American European consensus committee in 1994.
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease (COPD, interstitial lung disease, pulmonary hypertension)
- Contraindication to permissive hypercapnea (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Chandigarh、印度、160012
- 招聘中
- Respiratory intensive care unit, PGIMER
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接触:
- Ritesh Agarwal, MD, DM, MAMS, FCCP
- 电话号码:2756825 9914209825
- 邮箱:riteshpgi@gmail.com
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首席研究员:
- Arjun Srinivasan, M.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion Criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease
- Contraindication to permissive hypercapnia (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Adaptive support ventilation in ARDS
patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol
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patients are randomized to receive one of the two types of mechanical ventilation for ARDS
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有源比较器:conventional ventilation strategy in ARDS
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patients are randomized to receive one of the two types of mechanical ventilation for ARDS
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Duration of mechanical ventilation
大体时间:up to 4 weeks
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up to 4 weeks
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duration of ICU stay
大体时间:up to 4 weeks
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up to 4 weeks
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duration of hospital stay
大体时间:up to 8 weeks
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up to 8 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Mortality
大体时间:up to 8 weeks
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up to 8 weeks
|
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ease of use of ventilator mode
大体时间:up to 4 weeks
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up to 4 weeks
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frequency of blood gas analysis
大体时间:up to 4 weeks
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up to 4 weeks
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合作者和调查者
调查人员
- 首席研究员:Arjun srinivasan, M.D.、dept of pulmonary medicine & critical care, PGIMER
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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