- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07648342
Evaluation of Pupillometry as a Predictor of Pain Intensity Upon Withdrawal of Sedation in the Postoperative Period Following Cardiac Surgery: A Prospective Cohort Study (PUPREA)
Postoperative pain is a significant issue following surgery, and pain that is either inadequately treated or, conversely, overtreated can increase morbidity. For example, severe chest pain following cardiac or pulmonary surgery impairs the patient's respiratory rehabilitation, which can lead to fluid retention and, consequently, pneumonia. Conversely, overtreatment through excessive use of opioids can cause drowsiness and respiratory depression. Currently, planning postoperative pain management for intubated, ventilated, and sedated patients relies on indirect signs of pain assessed using scales, and on the clinician's subjective judgment. It is only after sedation is discontinued that the actual level of pain can be assessed, once the patient becomes communicative, which then allows analgesic treatment to be adjusted to the pain. This approach inevitably results in a period of discomfort and pain for the patient. In addition to semi-quantitative and subjective scales, a number of analgesia monitoring tools have been developed.
Among these, the use of pupillometry and the Pupillary Pain Index (PPI) during surgeries (gynecological, pediatric, cardiac) has been associated with a reduction in intraoperative opioid doses and a decrease in postoperative pain. In our department, pupillometry is routinely used to assess analgesia in intubated, ventilated, and sedated patients undergoing painful procedures. This method is integrated into standard care in the operating room in accordance with the PUCCAR study algorithm, as well as in the intensive care unit according to a specific departmental protocol, in addition to standard assessment scores. We hypothesize that performing pupillometry with a PPI score is predictive of pain intensity at extubation. If our hypothesis is confirmed, this would allow us to tailor analgesic management for each patient prior to discontinuing sedation.
연구 개요
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연락처 및 위치
연구 연락처
- 이름: Vivien BERTHOUD
- 전화번호: +33 06.72.76.00.74
- 이메일: vivien.berthoud@gmail.com
연구 장소
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Dijon, 프랑스, 21000
- Chu Dijon Bourogne
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연락하다:
- Vivien BERTHOUD
- 전화번호: +33 06.72.76.00.74
- 이메일: vivien.berthoud@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- A person who has given verbal consent
- An adult patient
- A patient scheduled for heart surgery
Exclusion Criteria:
- A person who is not enrolled in or eligible for a social security program
- A person subject to a legal protective measure (guardianship, conservatorship)
- Person subject to a judicial safeguard measure
- Pregnant, laboring, or breastfeeding woman
- Adult who is legally incapacitated or unable to give consent
- Minor
- Patient with preoperative cognitive impairment (MMS)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Patients scheduled for heart surgery
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Conducting pupillometry with a PPI score upon discontinuation of sedation in the intensive care unit
Measurement of pain intensity using the visual analog scale (VAS ou EVA)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain assessment using a visual analog scale
기간: Immediately after surgery
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First VAS (Visual Analog Scale, 0-10) measurement taken 5 to 15 minutes after extubation, as soon as the patient is able to communicate reliably.
Dichotomous variable: VAS >3 (severe pain) versus VAS ≤3 (tolerable pain).
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Immediately after surgery
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최초 제출
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연구 기록 업데이트
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기타 연구 ID 번호
- BERTHOUD 2026
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미국 FDA 규제 기기 제품 연구
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