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临床试验/NCT04263363
NCT04263363已完成4 期

A Prospective Digital Quality Improvement Project to Apply Best Clinical Practices to Patients at High Risk of Respiratory Complications

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 12,248 人开始时间: 2022年2月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
12,248
试验地点
1
主要终点
Time to "Fitness for Discharge" From the Recovery Room

研究概览

简要总结

The purpose of this study is to:

  1. Perform a retrospective analysis on data contained in the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction in the post-operative care unit (PACU) before and after the introduction of sugammadex into clinical practice.
  2. Develop and implement a clinical best practice pathway designed to prevent postoperative respiratory complications in higher risk patients (such as those with OSA or preexisting respiratory disease) using education and clinical decision support in patients.

详细描述

This will be a historical prospective comparative effectiveness clinical trial where the investigators plan to leverage their experience in extracting data from the EMR as well as creating robust CDS pathways in order to create and implement a pathway to promote use of best respiratory care in patients receiving general anesthesia who are at increased risk for postoperative respiratory dysfunction. The overall study will consist of two parts:

  1. Retrospective data analysis: The investigators will utilize the Perioperative Data Warehouse, a custom-built data warehouse, to study the effect of the introduction of sugammadex, a direct reversal agent for rocuronium, into clinical practice on time to "fitness for discharge" from the recovery room, as noted by the time the anesthesiologist places the discharge order, before and after intervention and postoperative respiratory dysfunction (as defined as duration of oxygen saturation below 90% in the PACU).
  2. Creation and implementation of a pathway to prevent postoperative respiratory dysfunction: The investigators will design and implement a perioperative decision support system which will identify high-risk patients and provide best practice recommendations via electronic clinical decision support reminders.

Creation and implementation of a pathway to prevent postoperative respiratory dysfunction:

In order to improve outcomes for high-risk patients who receive general anesthesia and paralysis the investigators will design and implement a perioperative decision support system which will identify high-risk patients and provide best practice recommendations via electronic clinical decision support reminders. While the exact parameters of the pathway will be designed based upon feedback from a group of quality leaders in the department, in general the pathway will function as follows:

When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive an alert reminding them of the best practice guidelines for pulmonary management in high-risk patients. As part of the study roll-out the investigators will present these guidelines with their quality committee, but anticipate that they will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • UCLA Ronald Reagan or Santa Monica patients aged 18 and older who had a general anesthetic with either rocuronium or vecuronium.
  • Patients who receive sugammadex from the specified study supply

排除标准

  • Patients under the age of 18
  • Patients with a preoperative glomerular filtration rate less than 30 or on hemodialysis
  • Patients with known hypersensitivity to any of the following: rocuronium, vecuronium, sugammadex, neostigmine or glycopyrrolate
  • Patients with known neuromuscular disease
  • Patients who remain intubated after surgery or leave the operating room with a tracheostomy in-situ
  • Patients who did not receive reversal of neuromuscular blockade (with neostigmine in the pre-period or sugammadex in the post-period).

研究组 & 干预措施

CDS pathway

Experimental

When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP

干预措施: Sugammadex 100 MG/ML [Bridion] (Drug)

结局指标

主要结局

Time to "Fitness for Discharge" From the Recovery Room

时间窗: One year prior to study intervention to one year following implementation of study intervention

The time the anesthesiologist places the discharge order

Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)

时间窗: One year prior to study intervention to one year following implementation of study intervention

Documentation oxygen saturation below 90%

次要结局

  • Percentage of Patients Who Had Train of Four Ratio Measurement(One year prior to study intervention to one year following implementation of study intervention)
  • Percentage of Patients Who Had Intraoperative Lung Protective Ventilation(One year prior to study intervention to one year following implementation of study intervention)
  • Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)(One year prior to study intervention to one year following implementation of study intervention)
  • Duration of Supplemental Oxygen Needed by High-risk Patients(One year prior to study intervention to one year following implementation of study intervention)
  • Postoperative Reintubation Rate(One year prior to study intervention to one year following implementation of study intervention)
  • Number of Patients With Unplanned Upgrade of Care(One year prior to study intervention to one year following implementation of study intervention)

研究者

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

Eilon Gabel, MD

Principal Investigator

University of California, Los Angeles

研究点 (1)

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