- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02630134
Device for Monitoring Pain During Intraoperative, Pre/Post Surgical Periods: Comparison With Standard of Care Monitoring
MyHealthTrendsTM Device for Pain for Monitoring Pain During the Intraoperative, Pre and Post Surgical Periods: Comparison With Standard of Care Pain Monitoring.
연구 개요
상세 설명
The MyHealthTrends™ for Pain Tracking System is a revolutionary consumer-oriented pain monitoring system enabling individuals to record the pain participants experience with the click of a button. Developed by a doctor for the ultimate use within hospital and outpatient settings, MyHealthTrends™ for Pain enables anyone afflicted with pain to easily record their sensations - helping to acquire faster and superior diagnoses and treatment. Among the benefits of the MyHealthTrends™ for Pain Tracking System are that it enables patients to: i] easily record the pain experienced in real-time - capturing accurate information; ii] shift from memory-based descriptions of experienced pain to data-driven, time based recordings; iii] provide objective evidence of the pain experienced.
It is extremely portable and convenient to carry, approximately the size of a modern automobile key. Since it can be uploaded to a confidential internet site by way of a computer, which site is then accessible to the physician, it provides various additional benefits. These include allowing the physician to: i] identify breakthrough pain episodes; ii] determine analgesic requirements with a real time detailed pain record; iii] prescribe the appropriate regimen with confidence; and iv] monitor pain levels experienced by the patient, free of distortion caused by memory biases and lapses.
The purpose of this study is to provide detailed and quantitative comparisons of the device's performance during a demanding clinical inpatient surgery episode, where standard pain monitoring and therapy are in use. The device is extremely easy to use involving merely the press of a button; and so it would not distract from any standard communication of pain symptoms, which the subject were inclined to convey. The device stores all information (time and date stamped) for downloading through a USB plug to a computer when the study is completed and the patient discharged.
Specifically, investigators will identify 40 post thoracotomy patients expected to receive a PCA or epidural for post op pain control at Tisch hospital. Patients will be given the device and asked to record their pain in the immediate post op period until discharge. The information obtained from the electronic diary will be correlated with pain records based on nurse's chart, administration of pain medication, VAS pain questionnaire instruments given daily to each patient, and call button utilization.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
New York
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New York, New York, 미국, 10016
- NYU Langone Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 or older
- post thoracotomy with a consult placed to the acute pain service on post-op day 0 for management of a PCA or epidural
- mental status permits patient to reliably press a button to record pain or administer medications
- must be hemodynamically stable
- must be able to physically use the MyHealth trends diary (press a button)
- supplies written informed consent.
Exclusion Criteria:
- less than 18 years of age
- has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the use of the MyHealth trends device (e.g. severe psychosis, quadrapalegic, etc.)
- Subject necessitates ICU care
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Baeta
These patients receive the Baeta device and take it home.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pain score
기간: 13 days
|
VAS score 0-10
|
13 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Compare regression of Baeta Daily Pain scores
기간: 13 days
|
Interpatient comparison of regression of Baeta Daily Pain Score as a function of VAS score - Correlation of inpatient and outpatient scores with chart indications of pain, VAS scores and observer scoring of pain behavior (none, mild, moderate, severe). |
13 days
|
Correlation of inpatient and outpatient scores with chart indications of pain, VAS scores and observer scoring of pain behavior
기간: 13 days
|
Comparing the patient's own scores and observers scoring the subject's pain
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13 days
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Number of cases in which the MHTTM for Pain is superior to standard pain monitoring techniques
기간: 13 days
|
Patients whose use indicated that the MHT TM is a better indicator of pain than standard techniques
|
13 days
|
Number of cases in which the MHTTM for Pain is inferior to standard pain monitoring techniques
기간: 13 days
|
Patients whose use indicated MHT TM was an inferior indicator of pain than standard techniques.
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13 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael Haile, MD, NYU School of Medicine
간행물 및 유용한 링크
일반 간행물
- Gaertner J, Elsner F, Pollmann-Dahmen K, Radbruch L, Sabatowski R. Electronic pain diary: a randomized crossover study. J Pain Symptom Manage. 2004 Sep;28(3):259-67. doi: 10.1016/j.jpainsymman.2003.12.017. Erratum In: J Pain Symptom Manage. 2004 Dec;28(6):626.
- Marceau LD, Link C, Jamison RN, Carolan S. Electronic diaries as a tool to improve pain management: is there any evidence? Pain Med. 2007 Oct;8 Suppl 3:S101-9. doi: 10.1111/j.1526-4637.2007.00374.x.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 11-00520
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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