跳至主要内容
临床试验/NCT05912855
NCT05912855尚未招募不适用

To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients

Tianjin Medical University General Hospital0 个研究点目标入组 110 人开始时间: 2023年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
主要终点
Value of qNOX with BPS≥5

研究概览

简要总结

Purpose: To explore the effect of analgesic management under the guidance of qNOX monitoring on the comfort level and prognosis of patients with mechanical ventilation in ICU.

Method:After admission to ICU, the patients were randomly divided into the analgesia group guided by BPS(Behavioral Pain Scale) and physiological indicators monitoring and qNOX-guided analgesia group (qNOX group). Sedation and analgesia program after admission to ICU (continuous injection pump) : propofol 1.5-4.5mg/kg.h, remifentanil 5-8ug/kg.h, maintain sedation goals RASS(Richmond Agitation-Sedation Scale)-3 to -4 scores, BPS(Behavioral Pain Scale)3 to 4 scores. The researchers worked with the bedside nurse to plan different care procedures, including :1) central venous catheter or arterial catheter puncture; 2) The patient is turned over completely so that the back can be washed and the sheets changed; 3) Endotracheal sputum aspiration (patients with intubation or in tracheotomy state ); 4) Dressing the wound.

Primary outcome:Value of qNOX at BPS(Behavioral Pain Scale)≥5 (qNOX sensitivity, specificity, positive predictive value and negative predictive value) Secondary outcome:To investigate the patient baseline variables that may affect qNOX; Variables that may influence qNOX in relation to critical illness.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years or older who are undergoing abdominal, orthopedic, ENT(ear-nose-throat), urological, neurosurgical or cardiothoracic surgery and require ICU treatment with mechanical ventilation while having an RASS(Richmond Agitation-Sedation Scale)-3 or -4 score;
  • Patients unable to self-assess pain intensity using NRS(Numerical Pain Rating Scale);
  • Patients who have provided informed consent.

排除标准

  • < 18 years of age;
  • Pregnant individuals;
  • Patients with communication impairments, such as those who have experienced cerebrovascular accidents;
  • A decision to withdraw life-sustaining treatment or an unstable medical condition that disrupts planned routine care.

结局指标

主要结局

Value of qNOX with BPS≥5

时间窗: During procedure

Sensitivity, specificity, positive predictive value and negative predictive value of qNOX.

次要结局

未报告次要终点

研究者

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

Guolin Wang

Professor

Tianjin Medical University General Hospital

相似试验