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Cognition and the Immunology of Postoperative Outcomes

2021년 3월 10일 업데이트: Deborah Culley, MD, Brigham and Women's Hospital
This research will test the hypothesis that immune system disequilibrium / dysfunction explains why preoperative cognitive impairment is a strong predictor of postoperative morbidity in older surgical patients. The investigators propose that cognitive impairment influences surgical morbidity because of underlying immune disequilibrium / dysfunction (risk marker) and that this shapes the immune response to surgery and defines immunological hallmarks of postoperative morbidity (disease marker). The overarching goal of this application therefore is to define and better understand the clinical immunology underlying the relationship between cognition and geriatric surgical morbidity.

연구 개요

상세 설명

This project is designed as a prospective, single-center observational study. The cohort will consist of 600 consenting subjects ≥ 65 years of age that agree to have a study investigator speak with them during their preoperative evaluation prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 65 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spinal surgery. Exclusion criteria will include history of stroke (not including transient ischemic attacks, or TIAs) or brain tumor, a history of autoimmune disorders, medications likely to significantly impact inflammation (e.g. steroids), current infection, uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions); limited use of the dominant hand (limited ability to draw); and or inability to speak, read, or understand English.

Patients will be introduced to the study through a flyer provided to them as part of a packet from their surgeon's office. A study team member will speak with those who have agreed during their preoperative evaluation to discuss studies from the department of Anesthesiology and satisfy eligibility criteria. After obtaining informed verbal consent over the telephone, study staff will gain information about the patient's age and years of education. Study staff will conduct the following preoperative measures over the telephone: the Geriatric Depression Scale-Short (GDS), the Beck Anxiety Inventory (BAI), the Visual Analog Scale for Pain (VAS), the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale (FRAIL), Instrumental Activities of daily living (IADLs), the Brief Pain Inventory (BPI), the World Health Organization Disability Assessment Schedule (WHODAS). In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members), and whether they have ever tested positive for COVID-19 in a patient survey. The study staff will administer the Montreal Cognitive Assessment (MOCA) simple cognitive screening tool that takes less than 10 minutes to complete and has little or no education, language, or race bias. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will be advised to expect a follow up telephone up to 3, 6, and 12- months after surgery to verify data elements and reassess functional outcome.

Delirium will be assessed prospectively once per day on postoperative days 1, 2, and/or 3 by a trained study team member using the Confusion Assessment Method [CAM] if the patient remains in the hospital and agrees to the evaluation. Delirium by chart review and CAM-ICU scores from the nursing staff will also be documented. Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. To evaluate cognition and functional status, the MOCA and the WHODAS will be administered 3, 6, and 12- months postoperatively by study staff over the telephone if the patient can be contacted and continue to agree to participate. The investigators will also collect information on secondary outcomes including whether they had a surgical procedure, time to postoperative anesthesia care unit (PACU) discharge, discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day, 6-month, and 1-year mortality when available. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.

연구 유형

관찰

등록 (예상)

600

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • 모병
        • Brigham & Women's Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Gregory J Crosby, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

65년 이상 (고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

The cohort will consist of 600 consenting subjects ≥ 65 years of age who present for preoperative evaluation prior to elective spine surgery.

설명

Inclusion Criteria:

  • Patients ≥ 65 years of age
  • American Society of Anesthesiologists (ASA) physical status of I-III
  • Scheduled for elective spine surgery.

Exclusion Criteria:

  • History of stroke (not including transient ischemic attacks, or TIAs)
  • History of brain tumor
  • History of autoimmune disorders
  • Medications likely to significantly impact inflammation (e.g. steroids)
  • Current infection
  • Uncorrected vision or hearing impairment
  • limited use of the dominant hand (limited ability to draw)
  • inability to speak, read, or understand English.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Older (≥ 65 years of age)
Older surgical patients presenting for elective spine surgery.
This is an observational study with no interventions.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
MOCA Score, Delirium, and Plasma Inflammatory Mediators
기간: 5 years
The investigators will evaluate correlations between preoperative cognition, as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative plasma inflammatory markers by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
5 years
MOCA Score, Delirium, and the Cellular Immune Response
기간: 5 years
The investigators will evaluate correlations between preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative monocyte immune gene transcriptome ex vivo to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
5 years
MOCA Score, Delirium and Extracellular Vesicle Immune Responses to Surgery.
기간: 5 years
The investigators will evaluate correlations between poor preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative proteins found in circulating extracellular vesicles by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
5 years

2차 결과 측정

결과 측정
측정값 설명
기간
Newly diagnosed perioperative health complications
기간: Up to 30 days after the surgical procedure
Newly diagnosed Myocardial Infarction, congestive heart failure (CHF), Cardiac Arrest, Arrythmia, Pneumonia, pulmonary embolism (PE), Reintubation, Stroke, Delirium, Coma>24h, deep wound infection,Superficial wound infection, Sepsis, Renal Failure, urinary tract infection (UTI), Reoperation, deep vein thrombosis (DVT), intensive care unit (ICU) admission following the subjects initial surgical procedure.
Up to 30 days after the surgical procedure
Discharge location (Home vs. other than home) on the day of patient discharge from hospital
기간: Up to 30 days after the surgical procedure
Whether the patient was discharge to their home or discharged to a place other than home such as rehabilitation center or skilled nursing facility.
Up to 30 days after the surgical procedure
30 day mortality
기간: 30 days after surgical procedure
Patient mortality 30 days after surgical procedure
30 days after surgical procedure
30 day re-operation or readmission
기간: 30 days after surgical procedure
Patient readmission to the hospital or reoperation 30 days after surgical procedure
30 days after surgical procedure
6 month mortality
기간: 6 months after surgical procedure
Patient mortality 6 months after surgical procedure
6 months after surgical procedure
1 year mortality
기간: 1 year after surgical procedure
Patient mortality 1 year after surgical procedure
1 year after surgical procedure
Cognitive health outcome
기간: 3, 6, and 12-months after surgical procedure.
Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) measured approximately 3, 6, and 12-months following the patient's surgical procedure if the participant is willing to participate.
3, 6, and 12-months after surgical procedure.
Functional health outcome
기간: Between 6 and 12-months after surgical procedure.
Functional health outcome measured with the World Health Organization Disability Assessment Score (WHODAS, 12-item, minimum score 0 maximum score 110 with higher score reflecting more disability) approximately 6 months to 1 year following the patient's surgical procedure if the participant can be contacted by followup phone call and is willing to participate.
Between 6 and 12-months after surgical procedure.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Gregory J Crosby, MD, Brigham & Women's Hospital; Harvard Medical School

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 9월 6일

기본 완료 (예상)

2024년 7월 31일

연구 완료 (예상)

2025년 7월 31일

연구 등록 날짜

최초 제출

2021년 2월 26일

QC 기준을 충족하는 최초 제출

2021년 3월 8일

처음 게시됨 (실제)

2021년 3월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 3월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 3월 10일

마지막으로 확인됨

2021년 3월 1일

추가 정보

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아니

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