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临床试验/NCT03330496
NCT03330496已完成不适用

Using Machine-learning Algorithms to Assess Acute Pain in Nonverbal Infants

Stanford University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Pain Measurement (all infants)

研究概览

简要总结

Pain assessments in non-verbal, critically ill infants represent an important clinical challenge. Older children or adults can easily express their pain, but infants lack that capability. They frequently experience repetitive acute pain during routine ICU care, but their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant pain leads to immediate clinical instability and potentially long-term physical, behavioral, and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical complications and/or impaired brain growth. Bedside nurses currently assess pain using pain scores, before taking action to ameliorate pain. Pain scores increase nursing workload and provide subjective assessments, rather than objective data for evaluating infant pain. Consequently, infants exposed to skin-breaking procedures, surgery, or other painful conditions often receive variable and inconsistent pain management in the ICU. The investigators aim to develop a multimodal pain assessment system, using sensor fusion and novel machine learning algorithms to provide an objective measure of pain that is context-dependent and rater-independent. This will enhance the quality of pain management in ICUs and allow continuous pain monitoring in real-time.

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
1 Day 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All infants less than 6 months of corrected chronological age.
  • Infants admitted to the participating ICUs at LPCH (NICU, PICU, CVICU).
  • Require an acute painful procedure for routine clinical care.

排除标准

  • Newborns with birth trauma, intrapartum asphyxia (5-minute Apgar Score <4 or cord pH < 7.01), fetal growth restriction (birth weight < 5th percentile for gestation), congenital anomalies or metabolic disorders, or any kind of brain injury.
  • Newborns born to mothers with a history of heavy smoking or drug abuse (alcohol, cocaine, ketamine, heroin/other opiates) or psychiatric drugs used during this pregnancy.
  • Newborns and infants requiring positive pressure ventilation using a face mask (BiPAP) or endotracheal tube (conventional or high-frequency ventilators).
  • Newborns and infants receiving continuous infusions of opioid drugs (morphine, fentanyl, others) and nerve blocks or neuraxial analgesia affecting the site of the invasive procedure during the 24 hours prior to study entry. (Note: Infants receiving intermittent opioids or non-opioid analgesics (acetaminophen, ibuprofen, ketorolac, others) WILL NOT be excluded).
  • Newborns and infants with facial anomalies, injuries or other pathologies affecting the facial area.

结局指标

主要结局

Pain Measurement (all infants)

时间窗: 10 minutes

Visual Analogue Scale (VAS) measures pain intensity based on observer assessment on a scale from 1 to 10, where higher values indicate more intense pain.

次要结局

  • Pain Measurement (newborns 0-30 days)(8 minutes)
  • Pain Measurement(30 minutes)
  • Pain Measurement (infants 1-6 months)(3 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kanwaljeet Anand

Professor of Pediatrics, Anesthesiology, Perioperative & Pain Medicine

Stanford University

研究点 (1)

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