跳至主要内容
临床试验/NCT06732921
NCT06732921进行中(未招募)不适用

Protocol for a Pilot Interventional Study Evaluating the Efficiency and Safety of a Telemedicine Solution for the Post-Anesthesia Care Unit

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 8,500 人开始时间: 2023年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
8,500
试验地点
1
主要终点
Time spent in PACU

研究概览

简要总结

A pilot study in perioperative telemedicine that aims to demonstrate the efficiency, and safety of integrating telemedicine into the PACU environment. This pilot study will expand on our previously conducted proof-of-concept study for a telemedicine solution in the PACU. If this pilot study proves to be successful, the study team intends subsequently to expand such a telemedicine solution to multiple clinical locations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
否

入选标准

  • •Adults (18 years and older)
  • •Undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled.

排除标准

  • 未提供

研究组 & 干预措施

Recovery Control Tower (RCT)

Experimental

Clinicians in the RCT will remotely work with PACU clinicians to care for patients assigned to one of the two study bays. A version of AlertWatch® (AlertWatch, Ann Arbor, Michigan) decision-support software, customized for the PACU environment, will assist clinicians in the RCT to perform core PACU-related functions remotely. Caregility's iObserver, from the Caregility Cloud™ Virtual Care Platform, will be used for two-way video communication When feasible, RCT clinicians will join handoff activities from the OR to the PACU and discuss pertinent intraoperative events with clinical teams on the ground. RCT clinicians will document patient specific recovery tasks within AlertWatch to assist in tracking patient recovery progresses. RCT clinicians will be the initial point of contact for ongoing recovery care, such as order placements. The attending anesthesiologist in the RCT will assess patients' discharge readiness throughout their PACU stay.

干预措施: Alertwatch - Recovery Control Tower (Device)

结局指标

主要结局

Time spent in PACU

时间窗: Day of surgery

Time patient enters PACU to time patient leaves PACU

次要结局

  • PACU clinician satisfaction(Through study completion, an average of 1 year)
  • Time to PACU sign-out by anesthesia clinician(From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.)
  • Pain score in PACU(From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.)
  • Safety events - Return to hospital(24 hours)
  • Clinician interactions - Number of contacts RCT clinicians make to PACU clinicians for on-the-ground intervention(From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.)
  • PONV status in PACU(From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.)
  • Clinician interactions - Number of contacts RCT clinicians receive from PACU clinicians(From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.)
  • Safety events - Number of participants with elevation of care(24 Hours)
  • Safety events - Number of participants with administration of rescue drugs(24 Hours)
  • Safety events - Significant event notes(24 Hours)

研究者

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

Michael Avidan

Chair, Department of Anesthesiology

Washington University School of Medicine

研究点 (1)

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