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临床试验/NCT03186521
NCT03186521Unknown不适用

Impact of a Nurse Implemented Sedation and Analgesia Algorithm on Complications of Critical Illness and Outcome of Surgical Intensive Care Patients

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Duration of mechanical ventilation

研究概览

简要总结

To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. This, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.

详细描述

Outcome Measures : The primary objective of this non-invasive, non-interventional study is to show that the establishment of a titration algorithm for sedation and analgesia administered by nurses is more beneficial to the patient than the use of such a drug without a suitable regimen. The goal is to improve the quality of our painkillers and sedative drugs use needed in the intensive care environment in order to decrease the morbidity and mortality associated with it, without altering patient comfort and tolerance to the environment. For this we propose to collect a database including patient demographic details, pharmacological information and any possible complications during the ICU stay as well as a distant assessment exploring the psychological complications (3, 6 months and 1 year). The primary endpoint will be the duration of mechanical ventilation, and secondary endpoints, the length of stay in ICU and in hospital, mortality and other complications.

Methods: The two study populations will be in two distinct time periods, the first so-called control without any modification of practices, and the second, by introducing the algorithm with the same drugs being used. Quantitative comparisons of data following a normal distribution will be done using a Student's t test. Otherwise quantitative data will be compared using a Mann-Whitney test or Wilcoxon. The comparison of qualitative data will be done using a Fisher exact test. To increase the power of this before / after study, we calculated the number of patients to be included by period, based on the reduction in duration of mechanical ventilation with such protocols in the literature, and the mean duration of mechanical ventilation in our unit before the study.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Any patient sedated, intubated, ventilated whose anticipated duration of sedation is more than 48 hours.
  • Age greater than 18 years.

排除标准

  • Patient under guardianship or <
  • Comatose, intracranial hypertension, brain damage, Acute respiratory distress syndrom, acute severe asthma (therapeutic sedation), Post Cardiac Arrest care, Pregnancy
  • Neuromuscular blocking agents at the time of inclusion
  • Secondary Exclusion criteria:
  • Extubation <48 hours after inclusion
  • Deaths <48 hours after inclusion

结局指标

主要结局

Duration of mechanical ventilation

时间窗: baseline

Duration between endotracheale intubation and extubation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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