A Randomized, Double-blind, Controlled Trial of Cycling Continuous Sedative Infusions in Critically Ill Pediatric Patients Requiring Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Duration of Mechanical Ventilation Days
研究概览
简要总结
The purpose of this study is to determine if the reduction of the total amount of sedative critically pediatric ill patients receive in the PICU will achieve a significant decrease in mechanical ventilation days and a decrease in the overall length of stay in the PICU and hospital.
详细描述
Continuous sedative infusions have been associated with longer duration of mechanical ventilation, longer stay in the intensive care unit (PICU) and total hospital stay. Also, extended duration of continuous sedative infusions limits the ability to assess for adequate neurologic function.
There is, however, no published data on the use of daily interruption of continuous sedative infusions in pediatric patients, nor are there any recommendations from the leading pediatric critical care groups regarding this issue. Infants and children exposed to noxious stimuli (endotracheal tube, endotracheal suctioning, mechanical ventilation, indwelling catheters) in addition to an unknown environment are less likely to cooperate during normal daily interventions in the PICU. Continuous infusions of benzodiazepines and opioids in addition to as needed (PRN) bolus doses have been the standard of care in our institution for mechanically ventilated patients.
The study seeks to determine if reducing the total dose of sedatives, by holding them in a cyclical manner, will be a safe and effective intervention that will not increase adverse patient outcomes. This will be achieved by limiting the patient tolerance to the sedatives, decreasing the body total deposit of sedatives and subsequently decreases awakening time when patient is ready for extubation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 18 years of age
- •Intubated and mechanically ventilated
- •Expected to require continuous infusions of sedatives for at least 48 hours
- •Parent or legal guardian available for informed consent
- •Males and females of any race are eligible
排除标准
- •Less than 72 hours after surgery
- •Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- •Critical airway (according to PICU Attending)
- •Ventilator dependent (including noninvasive) on PICU admission
- •Greater than 48 hours of continuous sedation infusion(s)
- •Neuromuscular respiratory failure
- •Managed by patient controlled analgesia (PCA) or epidural catheter
- •Known allergy to any of the study medications (fentanyl or midazolam)
- •Family/Medical team have decided not to provide full support (patient treatment considered futile)
- •Patient requires ECMO
- •Head trauma requiring intracranial pressure monitoring
- •Pregnancy
- •Following resuscitation from cardiorespiratory arrest whose initial pH is < 6.9
- •ICU Attending judgment that patient should be excluded for safety reasons
研究组 & 干预措施
Experimental Group
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol
干预措施: Midazolam (Drug)
Experimental Group
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol
干预措施: Normal saline (Drug)
Experimental Group
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol
干预措施: Fentanyl (Drug)
Control Group
In this arm, midazolam and fentanyl were administered during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
干预措施: Midazolam (Drug)
Control Group
In this arm, midazolam and fentanyl were administered during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Duration of Mechanical Ventilation Days
时间窗: From date of randomization until the date of discharge from PICU, assessed up to 1 month
Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.
次要结局
- Hospital Length of Stay(From date of hospital admission to date of hospital discharge, assessed up to 6 weeks)
- PICU Length of Stay(From date of randomization until the date of discharge from PICU, assessed up to 1 month)
研究者
Javier Gelvez, MD
M.D.
Cook Children's Health Care System