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临床试验/NCT05399758
NCT05399758暂停不适用

Nociception Evaluated by the NOL® Index in Sedated Patients in the Intensive Care Unit

University of Chile2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
40
试验地点
2
主要终点
NOL monitor values

研究概览

简要总结

Due to their underlying pathology and the necessary complicated procedures to which they are exposed, patients in the intensive care unit experience varying degrees of pain at some point in their evolution. Evidence has established short-term and long-term negative consequences of unresolved pain or excessive analgesic sedation. However, pain assessment or adequate nociceptive monitoring remains a significant challenge, especially in non-communicative patients under deep sedation, who urgently need to expand and improve current tools.

Pain assessment in critically ill patients is challenging; limitations in their ability to communicate (neurocognitive deficit, use of endotracheal tube) or altered consciousness (deep sedation) make them unable to self-report their pain with standard pain scales. The Behavioral Pain Scale (BPS) and the Critical-Care Pain Observation Tool (CPOT) are the pain assessment tools with the best performance and reliability for patients in these conditions.

Different technologies are used to monitor nociceptive responses caused by surgical stress in patients under general anesthesia that together with the clinical evaluation, manage to keep patients in the best analgesic conditions, improving the post-surgical prognosis. In particular, the NOL® nociceptive index (Medasense, Ramat Gan, Israel) is a multiparametric detection of nociception/pain, delivering a dimensionless score (0 -100) calculated through an algorithm (patented) and based on the registry of four biometric sensors (photoplethysmography, galvanic skin response, temperature, and accelerometer). NOL index value between 10-25 is the most appropriate for maintaining analgesia during general anesthesia.

The ease and low invasiveness of this system (all sensors are implemented in a finger clip, similar to an oxygen saturation monitor) may allow its potential use in the context of intensive care unit patients. Some studies have recently been published that highlight the possible usefulness of the NOL® index in critically ill patients. However, in these studies, the assessment of nociception was limited to acute nociceptive procedures only.

详细描述

In the following protocol, we will study the feasibility of using the NOL® index to evaluate nociception in patients under sedation with propofol and opioid analgesics such as fentanyl.

This study aims to describe the feasibility of using the NOL® nociception index as an objective tool for assessing pain/nociception in patients with sedation in the Intensive Care Unit (ICU).

The values obtained with the use of the NOL® index will be recorded and compared with the standard measurements of pain assessment (Behavioral Pain Scale (BPS) and/or Critical-Care Pain Observation Tool (CPOT)) in patients with a deep/superficial sedation protocol (SAS 1-2). The values obtained after exposure to nociceptive stimuli such as interventions, cleaning, and invasive procedures, among others, will be registered.

In particular, scales such as CPOT and NOL® can be complementary since both measure different components related to pain. The CPOT measures expressive behaviors related to pain, and the NOL measures physiological parameters involved in the process of nociception, which can lead to pain.

Two other aims:

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ICU sedated patients under propofol and fentanyl

排除标准

  • Sedation duration less than 72 h
  • Opioid user before ICU hospitalization
  • Atrial fibrillation
  • Pregnancy/lactation
  • Patient with antiarrhythmic agents

结局指标

主要结局

NOL monitor values

时间窗: Day 3

Values will be recorded and compared with fentanyl dosage and clinical pain assesment

次要结局

  • Fentanyl dosage(Day 3)
  • Clinical pain assessment (Behavioral Pain Scale)(Day 3)
  • BIS index(Day 3)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonello Penna

Principal Investigator, Anesthesiologist, MD-PhD

University of Chile

研究点 (2)

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