Pilot Study for Sedation Interruption in Children
Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study
研究概览
地位
详细说明
This is a prospective single-center, superiority, open randomized controlled trial comparing sedation interruption protocol and routine continuous sedation in mechanically ventilation (MV) children.
The study will be conducted in the twelve beds Pediatric Intensive Care Unit (PICU) at the Montreal Children's Hospital, a pediatric tertiary care and teaching hospital.
Patients will be enrolled prospectively within 24 hours of intubation and MV. After obtaining written consent patients will then be randomized to interrupted sedation or standard sedation protocol. The investigators will randomize using a computer-generated sequence of random numbers.
A Sedation protocol will be used for both groups to adjust continuous infusions of sedatives/analgesics to a targeted Comfort-Behavior scale. In the intervention group, sedation infusions will be interrupted daily at 8:00 AM, this interruption will be continued until the patient is under-sedated according to the Comfort Behavior scale goals or in the presence of symptoms of hemodynamic instability or respiratory distress. Then the patient will receive a bolus of sedation and the infusion will be restarted at a dose 50% less than the previous dose to return to the Comfort Score goal.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Yasser Kazzaz, MBBS, FRCPC, FAAP
- 电话号码:6479892770
- 邮箱:yasser.md@gmail.com
研究联系人备份
- 姓名:Davinia Withington, BM FRCA MRCP
- 邮箱:davinia.withington@mcgill.ca
学习地点
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Quebec
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Montreal、Quebec、加拿大、H3H 1P3
- 招聘中
- Montreal Children's Hospital
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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:
- Intubated and mechanically ventilated patients due to respiratory failure of multiple etiologies or after major surgical procedures for more than 24 hours.
- Sedation managed by benzodiazepines and opioids infusions
Exclusion Criteria:
- If sedation is required as part of medical management (Pulmonary hypertension, Increase intracranial pressure, Seizures
- Trauma & burn admissions
- Patients resuscitated from cardiac arrest
- Allergy to sedation (midazolam)
- Allergy to analgesia (fentanyl, morphine)
- Difficult airway including post-operative airway surgeries. (As deemed by ICU physician in charge)
- High frequency oscillator
- Special gas as inhaled nitric oxide, or isoflurane.
- Chronic ventilatory support
- Neuromuscular diseases
- Corrected Gestational age less than 37 weeks.
- Patients not expected to survive to discharge as per attending physician.
- Palliative care patients.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Sedation Interruption Protocol + standard sedation protocol
Nurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
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有源比较器:Standard sedation protocol
Nurse directed protocol for administering sedation and/or analgesia.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Recruitment rate
大体时间:At 30 days
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The number of eligible patients who provided informed consent to participate in the study divided by the total number of eligible patients who were asked for informed consent during the pilot study period over 1 year period.
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At 30 days
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Adherence Rate
大体时间:At 30 days
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At 30 days
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Reasons for non-participation
大体时间:At 30 days
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At 30 days
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Duration of mechanical ventilation in hours.
大体时间:intraoperative
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Total number of hours between the moment patient was intubated to the moment of extubation.
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intraoperative
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合作者和调查者
调查人员
- 首席研究员:Conall Francoeur、McGill University Health Centre/Research Institute of the McGill University Health Centre
- 首席研究员:Christina Maratta、McGill University Health Centre/Research Institute of the McGill University Health Centre
- 首席研究员:Maryse Dagenais、McGill University Health Centre/Research Institute of the McGill University Health Centre
出版物和有用的链接
一般刊物
- Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
- Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
- Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.
- Anifantaki S, Prinianakis G, Vitsaksaki E, Katsouli V, Mari S, Symianakis A, Tassouli G, Tsaka E, Georgopoulos D. Daily interruption of sedative infusions in an adult medical-surgical intensive care unit: randomized controlled trial. J Adv Nurs. 2009 May;65(5):1054-60. doi: 10.1111/j.1365-2648.2009.04967.x.
- Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872. Erratum In: JAMA. 2013 Jan 16;309(3):237.
- Gupta K, Gupta VK, Jayashree M, Singhi S. Randomized controlled trial of interrupted versus continuous sedative infusions in ventilated children. Pediatr Crit Care Med. 2012 Mar;13(2):131-5. doi: 10.1097/PCC.0b013e31820aba48. Erratum In: Pediatr Crit Care Med. 2012 May;13(3):373. Muralindharan, Jayashree [corrected to Jayashree, Muralindharan].
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
与本研究相关的术语
其他研究编号
- 14-011-PED
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Sedation Interruption Protocol的临床试验
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HonorHealth Research InstituteCantex Pharmaceuticals终止