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临床试验/NCT06245005
NCT06245005已完成不适用

Investigation of a Novel Quantitative Measure of Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study

Ohio State University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Incidence of Lumosity 6-game brain exercise completion

研究概览

简要总结

Investigators will evaluate feasibility of using a custom 6-game Lumosity brain exercise experience in busy clinical areas to obtain a quick, quantitative measure of cognitive reserve (first gameplay performance [FGP]) in older patients presenting for major surgery. Participants in this feasibility trial will serve as a pilot population to estimate postoperative delirium incidence in patients willing and able to complete the brief, self-directed, brain exercise experience on a portable electronic device in various preoperative encounters, and will provide insight into which preoperative encounter (outpatient clinic or morning of surgery preoperative holding) may be more conducive to brief preoperative cognitive evaluations and interventions in future studies. First gameplay performance obtained during study procedures will be compared based upon postoperative delirium status (positive verse negative) to evaluate predictive value of the custom 6-game battery. This will guide future studies of FGP as a quick, quantitative measure of cognitive reserve in older surgical patients, with potentially more utility in preoperative patients than other assessments of cognitive function.

详细描述

Potential study participants will be identified by researchers monitoring The Ohio State University Preoperative Assessment Clinic (OPAC) and operating room (OR) schedules. Eligible patients will be contacted over-the-phone regarding willingness to participate. Surgeons will be made aware when their patients have been approached over the phone and updated accordingly if the patient agrees to be enrolled in the study. If willing, patients will be met at either their preoperative assessment at OPAC or their day of surgery at Preoperative Holding. Patients will be screened at this encounter for inclusion and exclusion criteria.

Following the initial screening encounter, patients will be required to provide informed consent prior to any study activities or data collection. Once informed consent is signed by both the subject and researcher, the researcher will provide the patient with a portable electronic device (laptop) with access to Lumosity brain exercise software (Lumos Labs, San Francisco, California, USA) and instruct participants to complete as many of the provided 6 games as possible. These 6 games were identified specifically from preliminary data indicating their postoperative delirium predictive capacity. Gameplay completion and performance scores will be coded and stored on the Lumosity software. Personal health information will not be used on the research device.

At this visit, the researcher will also collect demographic information (age, sex, body max index (BMI), ethnicity, and educational level) and relevant comorbidities via the Charlson Comorbidity Index (CCI). The research device will be collected at the end of the patient's visit at OPAC or just prior to surgery when in preoperative holding.

All patients will undergo surgery as planned. Time under anesthesia and type of surgery will be collected. On the first day following surgery, patients will be assessed by research members for the presence of delirium using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) at 0800 ± 2 hours and 1700 ± 2 hours. This will be repeated every postoperative day until postoperative day 7 or discharge, whichever comes first. Additionally, medical notes from the day of surgery to discharge or post-operative day (POD) 7 (whichever comes first) will be assessed for delirium by a researcher using a validated medical chart-based delirium assessment (CHART-DEL). Patients will be asked to complete the Discharge Survey Prior to hospital discharge or over the phone after discharge. In addition, their length of stay in the hospital and discharge location will be collected.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 60 years of age or older
  • Capable and willing to consent
  • Non-cardiac/non-neurological surgery with an expected hospital stay of at least 72 hours
  • Anticipated ASA physical status I-IV
  • English speaking
  • Willingness to use computer-based device

排除标准

  • Severe visual or auditory deficits
  • Surgery or procedure within the previous 6 months requiring general anesthesia
  • Active Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol, or drug abuse
  • ASA physical status V, VI
  • Planned postoperative ICU admission
  • Preoperative benzodiazepine administration (i.e. Midazolam, Diazepam)

研究组 & 干预措施

OPAC

Feasibility to conduct brain exercise gameplay on a portable electronic device at Ohio State Preoperative Assessment Clinic (OPAC)

干预措施: Brain exercise gameplay on a portable electronic device (Device)

PREOP

Feasibility to conduct brain exercise gameplay on a portable electronic device at The Wexner Medical Center Preoperative Holding Areas.

干预措施: Brain exercise gameplay on a portable electronic device (Device)

结局指标

主要结局

Incidence of Lumosity 6-game brain exercise completion

时间窗: up to 30 minutes after participants start the first Lumosity game brain exercise

Determine if brain exercise gameplay on a portable electronic device is feasible in two different preoperative settings (The Ohio State Preoperative Assessment Clinic (OPAC) and The Wexner Medical Center Preoperative Holding Areas).

次要结局

  • Incidence of Postoperative Delirium(through study completion, an average of 7 days)

研究者

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

Michelle Humeidan

Associate Professor

Ohio State University

研究点 (1)

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