Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated Chronic Obstructive Pulmonary Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- ∆Raw (the Difference Between Measured and Target Airway Resistance)
研究概览
简要总结
This study evaluates whether individualized dosing schedule of inhaled bronchodilator is more effective than fixed dosing in reducing airway resistance of intubated COPD patients.
详细描述
*Study Design
- This is an open-label, randomized controlled study comparing individualized versus fixed bronchodilator dosing schedule for patients with COPD with acute respiratory failure.
*Patients Enrollment
- We will collect 100 patients just admitted to the intensive care unit of Changhua Christian Hospital (Changhua, Taiwan) due to COPD with acute respiratory failure.All participants will be randomly assigned to either group according to a computer-generated allocation sequence in block size of 4 patients.
*Airway Resistance (Raw) Determination
- Enrolled patients will be ventilated by either AVEA (CareFusion, Yorba Linda, CA, USA),e500 (Newport Medical Instrument Inc. CA, USA) or Eivta 4 (Drager) ventilator. When evaluating Raw, the ventilator settings will be transiently switched to volume control mode with fixed tidal volume (500 ml) and constant flow (with a rate of 60 L/min). Plateau pressure is measured by manually controlled end-inspiratory pause12. Every effort will be exercised to avoid excessive airway secretion or patient agitation during measurement. Each measurement will be repeated three times with an interval of at lease 1 minute and calculate their average. Raw will be calculated by an equation of (peak inspiratory pressure - plateau pressure)/flow. After each measurement, the ventilator will soon be reverted to its usual settings. Raw will be routinely determined every 8 hours for 28 days if the ventilator is not discontinued.
*Technique of Metered Dose Inhaler (MDI) administration through endotracheal tube
- The technique basically follows the recommendation of Dhand and Guntur. Airway secretions should be sucked out before drug administration. Heat moisture exchanger, but not humidifier, is removed. After shaking and warming MDI to hand temperature, the canister is connected to an AeroChamber HC MV spacer (Trudell Medical International, London, Canada) placed in the inspiratory limb of ventilator circuit 15 cm away from the endotracheal tube. Actuation is synchronized with the initiation of inspiration. Each actuation is at least 15 second apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •chronic obstructive pulmonary disease
- •acute respiratory failure under ventilator support for less than 72 hours
- •endotracheal tube inserted
排除标准
- •confirmed asthma
- •Acute Physiology and Chronic Health Evaluation II score over 35
- •a co-morbidity of septic shock
研究组 & 干预措施
Fixed dosing
- Ventilator support
- Determining personal target airway resistance
- Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent
- Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days
- Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days
- No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met
干预措施: Bronchodilators inhalation (Drug)
Individualized dosing
- Ventilator support
- Determining personal target airway resistance
- Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent
- Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days
- Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days
- Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met (until ventilator discontinuation or the 28th day if ventilator-dependent)
干预措施: Bronchodilators inhalation (Drug)
结局指标
主要结局
∆Raw (the Difference Between Measured and Target Airway Resistance)
时间窗: Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame.
The value can be expressed as relative deviation from target =(measured Raw - target Raw)/target Raw X100
Rapidity of ∆Raw Change
时间窗: Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame.
The deviation of ∆Raw from the personal target, which was calculated as (measured Raw-target Raw)/target Raw multiplied by 100.
次要结局
- Ventilator-free Days From Day 1 to 28(From day 1 to day 28 after enrollment)
- Number of Total Puff of Rescue Short-acting Bronchodilator(the 28th day after enrollment)
- The Participants of Breathing Without Assistance by Day 28(the 28th day after enrollment)
- Number of Episode of Nosocomial Pneumonia(the 28th day after enrollment)
- Numbers of Episode of Drug-related Adverse Effect(From day 1 to day 28 after enrollment)
- Mortality Rate(the 180th day after enrollment)
研究者
Shin-hwar Wu
Attending physician
Changhua Christian Hospital
