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临床试验/NCT05131633
NCT05131633已完成不适用

Point-of-care Regional Anaesthesia in Intensive Care Unit. A Multicentric Professional Practice Evaluation

University Hospital, Clermont-Ferrand9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
9
主要终点
Our primary objective is to assess the global use of RA in ICU/stepdown units

研究概览

简要总结

Pain is a major problem in Intensive Care Unit (ICU). Adequate pain management not only means decreasing the pain intensity, but also improving the functionality and allowing the early mobilization that is a prerequisite for improving recovery and decreasing the risk of complications in ICU. The complex problems involved in pain, analgesic interventions, and outcome have been emphasized in several surveys over the past decades, but apparently with only small improvements, despite the existence of several guidelines for perioperative pain management.

Regional analgesia techniques (peripheral and neuraxial nerve blocks) have the potential to decrease the physiological stress response to trauma or surgery, reducing the possibility of surgical complications and improving the outcomes. Recent studies suggested that surgical and trauma ICU patients receive opioid-hypnotics continuous infusions to prevent pain and agitation that could increase the risk of posttraumatic stress disorder and chronic neuropathic pain symptoms, and chronic opioid use. Also they may reduce the total amount of opioid analgesics necessary to achieve adequate pain control and the development of potentially dangerous side effects. The use of the regional anesthesia technique in the ICU, however, can, in part, be limited by the presence of hemodynamic instability, bleeding diathesis, and by the fear of the performing procedures potentially associated with significant side effects in heavily sedated patients.

Although regional anesthesia emerges as a new and very interesting player for pain management in ICU, today very few data exists about the use of RA (including PNB and neuraxial nerves blocks) by the practicians in ICU/stepdown units. The main objective of this study is to assess the use of RA for pain management both initiates in the operative room for surgical patients then transferred in ICU/stepdown units and performs directly by the practicians in ICU/stepdown units, in several french units.

详细描述

Taken together, previous data indicate that regional anesthesia emerges as a new and very interesting player for pain management in ICU.

Because very few data exist about the use of RA (including PNB and neuraxial nerves blocks) by the practicians in ICU we, therefore, design this multicentric professional practice evaluation to :

  • (1) , assess the use of RA in ICU/stepdown units but initiates by anesthesiologist in the operative room
  • (2) , assess the use of RA in ICU/stepdown units directly perform by practicians in ICU
  • (3) , describe the type, modalities and indications of RA performed

This study will have no effect on the management of the ICU/stepdown units patients.

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

入选标准

  • ○ All medical, surgical, and trauma patients hospitalized in the participating centers and receiving RA during the one-week study period.

排除标准

  • Opposition to the processing of personal data
  • Age <18 years old
  • Absolute contraindications to the perform RA
  • Previous hypersensitivity or anaphylactic reaction to local anesthetics
  • Patient under a tutelage measure or placed under judicial protection

结局指标

主要结局

Our primary objective is to assess the global use of RA in ICU/stepdown units

时间窗: During 1 week of the study

. Number (prevalence) of RA performed in ICU over 1 week.

次要结局

  • Type of RA(During 1 week of the study)
  • assess the use, in ICU/stepdown units patients, of RA previously initiated in the operative room by an anesthesiologist(During 1 week of the study)
  • Indications for RA(During 1 week of the study)
  • Duration of catheter(During 1 week of the study)
  • Evaluation of vital status: on ICU/stepdown units discharge(Day 28 after the RA)
  • Name of local anesthetics used(During 1 week of the study)
  • Evaluation of analgesia(During 1 week of the study)
  • Evaluation of success or not in RA(During 1 week of the study)
  • Complication of RA(During 1 week of the study)
  • Reason for removal cathete(During 1 week of the study)
  • Who perform RA(During 1 week of the study)
  • Technical management to perform RA(During 1 week of the study)
  • ICU/stepdown units length of stay(Day 28 after the RA)
  • Location of RA(During 1 week of the study)
  • Concentration of local anesthetics used(During 1 week of the study)
  • Contraindication for RA(During 1 week of the study)
  • Hospital length of stay(Day 28 after the RA)
  • Evaluation of vital status at day 28(Day 28 after the RA)
  • Ventilator-free days to day 28(Day 28 after the RA)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Blondonnet Raïko

Dr

University Hospital, Clermont-Ferrand

研究点 (9)

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