Individualized Analgesia in the Intensive Care Unit With a New Pain Assessment Bundle and Protocolized Analgesia Adjustments (INVISIBLE) - an Observational Single-Centre Study in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Oral morphine equivalent (OME) per day of mechanical ventilation.
研究概览
简要总结
Both severe pain and opioid therapy are associated with negative effects. The experience of pain is common in the intensive care unit, but it is highly individual and difficult to assess, as patients are often unable to communicate. This especially applies to patients who are mechanically ventilated. Behavioral assessment tools can help to identify pain in this population, but do not register overdose of opioid therapy. The AlgiScan® delivers the Pupillary Pain Index (PPI), an objective assessment of nociception level, which has been shown to be useful in small studies with respect to reduction of opioid dose without leading to more pain.
New institutional protocols for the assessment of pain include the behavioral pain assessment tool Zurich Observational Pain Assessment (ZOPA) and the PPI. This project aims to evaluate the impact of the new institutional protocols on opioid administration and occurrence of pain compared to a historical cohort by analyzing routinely collected data during mechanical ventilation (Part A). In a second part (Part B), promising biomarkers for detection of pain, subjective ratings by nurses and physicians and an additional behavioral pain scale will be evaluated using an observational study design. After screening and enrolment (day 1/visit 1), characteristics of pain will be assessed on 4 occasions during 2 days (day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5). On visit 2 and 4, biomarkers (alpha-amylase, cortisol) will be sampled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Admission to the intensive care unit
- •Adults (≥18 years) of all sex and gender
- •Mechanical ventilation Part B
- •Admission to the intensive care unit
- •Adults (≥18 years) of all sex and gender
- •mechanical ventilation
- •Continuous opioid therapy
- •Richmond Agitation Sedation Scale (RASS) ≤ -4
- •Presumed duration of mechanical ventilation until the end of observations (until day 3)
- •Established vascular access suitable for blood sampling independent of study inclusion (arterial line or central venous catheter)
排除标准
- •None Part B
- •Previous enrolment into the current investigation
- •Tracheostomy
- •Chronic opioid use
- •Regional anaesthesia
- •Implanted pacemaker device
- •Allergy to silicone or ECG-electrodes
- •Ophthalmologic disease (e.g. ocular trauma, glaucoma) or past eye surgery
- •Fixed pupils
- •Known or suspected neurologic disease (including hypoxic encephalopathy)
- •Therapy with atropine or topical mydriatics in previous 24 hours or planned
- •Therapy with systemic steroids in previous 24 hours or planned
- •Therapy with neuromuscular blocking agents in previous 24 hours or planned
- •Stomatitis
- •Active oral or nasal bleeding
研究组 & 干预措施
Prospective Cohort
Critically ill and mechanical ventilated patients after implementation of a new institutional protocol for pain assessment and analgesia adjustments
Historic Cohort
Critically ill and mechanical ventilated patients before implementation of a new institutional protocol for pain assessment and analgesia adjustments
结局指标
主要结局
Oral morphine equivalent (OME) per day of mechanical ventilation.
时间窗: Part A: during mechanical ventilation (up to 28 days)
OME is a standardized method to quantify and compare the potency of different opioid drugs by converting their doses into the equivalent amount of oral morphine. Doses are weighted based on the potency of the opioid and then summarized into a final value. Days of mechanical ventilation are weighted based on the hours of mechanical ventilation divided by 24 hours (relevant for days of intubation and extubation).
次要结局
- Trust in the Zurich Observational Pain Assessment (ZOPA)(Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5)
- Sufentanil dose per day of mechanical ventilation(Part A: during mechanical ventilation (up to 28 days))
- Opioid dose adjustments - Number of adjustments(Part A: during mechanical ventilation (up to 28 days))
- Opioid dose adjustments - Relative change during pain assessment(Part A: during mechanical ventilation (up to 28 days))
- Number of rescue analgesics administered per day(Part A: during mechanical ventilation (up to 28 days))
- Occurrence of adverse effects of pain per day of mechanical ventilation(Part A: during mechanical ventilation (up to 28 days))
- Number of sedatives used per day of mechanical ventilation(Part A: during mechanical ventilation (up to 28 days))
- Richmond Agitation Sedation Scale (RASS) < -3(Part A: during mechanical ventilation (up to 28 days))
- Time to extubation(Part A: From time of stop of analgosedation (during mechanical ventilation, up to 28 days) until extubation (up to 7 days). Events such as death or referrals while being intubated will be censored.)
- Opioid prescription at ICU discharge(Part A: at ICU discharge assessed up to 5 days)
- Opioid prescription at hospital discharge(Part A: at hospital discharge assessed up to 10 days)
- Target nociception level(Part A: during mechanical ventilation (up to 28 days))
- Opioid-free days in the ICU(Part A: from ICU admission to ICU discharge (up to 100 days))
- Pupillary Pain Index(- Part A: During mechanical ventilation - Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5)
- Cortisol(Part B: day 2/visit 2, day 3/visit 4)
- Amylase(Part B: day 2/visit 2, day 3/visit 4)
- Critical Care Pain Observation Tool (CPOT)(Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5)
- Subjective pain rating(Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5)
- Subjective rating of nociception level(Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5)
- Trust in the Pupillary Pain Index (PPI)(Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5)
- Pupil size before stimulation(Part A: during mechanical ventilation (up to 28 days))
- Percentage pupil's variation(Part A: during mechanical ventilation (up to 28 days))
- Maximal size variation(Part A: during mechanical ventilation (up to 28 days))
- Neuron-specific Enolase (NSE) [mcg/L](Part A: From cardiac arrest until 72 hours after cardiac arrest)
- Zurich Observational Pain Assessment (ZOPA)(Part A: during mechanical ventilation Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5)