- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04792983
Cognition and the Immunology of Postoperative Outcomes
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
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Gregory J Crosby, MD
- 전화번호: 617-732-7398
- 이메일: gcrosby@bwh.harvard.edu
연구 연락처 백업
- 이름: Erin J Kim, BA
- 전화번호: 7034088957
- 이메일: ekim56@bwh.harvard.edu
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- 모병
- Brigham & Women's Hospital
-
연락하다:
- Sierra J Loomis, BA
- 전화번호: 617-278-0949
- 이메일: saloomis@bwh.harvard.edu
-
연락하다:
- Erin J Kim, BA
- 전화번호: 6177320949
- 이메일: ekim56@bwh.harvard.edu
-
수석 연구원:
- Gregory J Crosby, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
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
수사관
- 수석 연구원: Gregory J Crosby, MD, Brigham & Women's Hospital; Harvard Medical School
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .