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临床试验/NCT04422808
NCT04422808已完成不适用

Assessing Current Analgesia and Sedation Weaning Practices in Adult Critically Ill Patients

Wilkes University1 个研究点 分布在 1 个国家目标入组 2,437 人开始时间: 2021年6月1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
2,437
试验地点
1
主要终点
Number patients weaned from parenteral analgesics

研究概览

简要总结

Withdrawal from opioids and sedatives administered for medical purposes (i.e. iatrogenic withdrawal) often goes unrecognized in the critically ill, but its prevalence is high. Reports describing what is being implemented at the bedside to prevent iatrogenic withdrawal are lacking, and how patients are monitored and assessed for withdrawal has not been adequately studied. Therefore, the investigators overall objective is to determine the current analgesia and sedation weaning practices in adult ICUs. In order to accomplish this objective the investigators plan to conduct a prospective, observational, point prevalence trial. Data from this project will help support future investigation of iatrogenic withdrawal.

详细描述

The design for this study will be an international, prospective, observational, point prevalence trial. The investigators plan to recruit multiple sites to participate in the study through the use of professional organization list serves as well as direct outreach to colleagues and associates of members of the investigator team. Data collection will be performed by site investigators on one single day for all patients currently in the ICU who meet inclusion criteria on the data collection day. Site investigators will have an approximately three-month time frame in which to choose a data collection date. All data collection will be performed using REDcap, a secure web-based data collection tool that meets the HIPAA (Health Insurance Portability and Accountability Act of 1996) requirements for protection of patient health information. Utilization of this system will allow real-time input of data from the patient's bedside by site investigators. Data collected will include various site and patient demographic data. The investigators will also collect opioid and sedative doses, durations of therapy, weaning of doses, and withdrawal assessment results.

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

  • All patients 18 years and older admitted to an adult intensive care unit on the day of data collection who have received parenteral analgesics or sedatives in the previous 24 hours.

排除标准

  • Patients who have not received parenteral analgesics or sedatives in the previous 24 hours.

结局指标

主要结局

Number patients weaned from parenteral analgesics

时间窗: Three months

The primary outcome will be the number of patients who are weaned from continuous parenteral analgesics and sedatives using a standardized approach. Continuous analgesic and sedative administration will be defined as those given as a continuous intravenous infusion, scheduled intermittent intravenous or subcutaneous injections, or as needed with at least half of the possible doses in a 24 hour period being administered.

次要结局

  • Patient proportion(Three months)
  • Number of patients assessed(three months)
  • Assessment tools(three months)
  • Standardized approach patients(three months)
  • Utilized analgesic and sedative weaning practice(three months)

研究者

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

Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP

Associate Professor

Wilkes University

研究点 (1)

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