- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07572539
The Accuracy of Peripheral Perfusion Index and Inferior Vena Cava Collapsibility Index for Predicting Hypotension in Patients Undergoing Shoulder Arthroscopy in Beach Chair Position:
The Accuracy of Peripheral Perfusion Index and Inferior Vena Cava Collapsibility Index for Predicting Hypotension in Patients Undergoing Shoulder Arthroscopy in Beach Chair Position: A Prospective Observational Study
This study will assess the accuracy of Peripheral Perfusion Index and inferior vena cava collapsibility index as predictive tools for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position under general anesthesia, contributing to the broader understanding of its role in perioperative hemodynamic management.
Primary outcome The accuracy of Peripheral Perfusion Index for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position Secondary outcomes
- Incidence of hypotension.
- Amount of administered fluids and total dose of vasopressors.
- The diagnostic accuracy of inferior vena cava collapsibility index in predicting hypotension.
연구 개요
상태
상세 설명
Shoulder arthroscopy is a minimally invasive surgical procedure widely utilized for the diagnosis and treatment of various shoulder joint pathologies, it is commonly performed with patients positioned in the beach chair position , which enhances access to the shoulder joint.
In the beach chair position, the patient is placed in in a semi-sitting position with an angle ranging from 30-60 degrees, depending on surgeon preference and procedure requirements. The lower extremities are typically slightly flexed. Patient's head is securely supported using a specialized head rest or padding while the operative arm draped freely or positioned using a mechanical arm holder for optimal access to the shoulder joint.
Nonetheless, the beach chair position has unique physiological challenges including reduced venous return, decreased cardiac output which eventually results in an increased risk of hypotension. Hypotension during surgery can compromise organ perfusion, potentially leading to cerebral ischemia, myocardial dysfunction, and delayed recovery, thus blood pressure monitoring across the procedure is crucial for optimizing patient safety, outcomes and to prevent potential complications.
Various parameters have been implemented to predict hypotension in beach chair position including; pre-induction values of mean arterial pressure , stroke volume variation , cardiac index and stroke volume index but the inconsistent sensitivity and specificity, together with the necessity for invasive monitoring, may limit their routine use.
Ultrasound measurement of the inferior vena cava collapsibility index and inferior vena cava diameter has the advantages of easy performance, repeatability and low cost and has often been used to predict fluid responsiveness in emergency and critical care settings. Recently, this noninvasive hemodynamic assessment method was introduced to predict post induction hypotension in the operating room . However, its utility remains controversial across different population settings and different types of anaesthesia.
Peripheral Perfusion Index is a non-invasive measure of peripheral perfusion. It is derived from the ratio of pulsatile to non-pulsatile blood flow as measured by photoplethysmography, it measures the central hemodynamics reflecting both vascular tone and cardiac output in patients undergoing general anesthesia, and a correlation between low PPI and low blood volume has been reported. As an emerging clinical tool it helps in early detection of hemodynamic instability.
This study will assess the accuracy of Peripheral Perfusion Index and inferior vena cava collapsibility index as predictive tools for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position under general anesthesia, contributing to the broader understanding of its role in perioperative hemodynamic management.
Primary outcome The accuracy of Peripheral Perfusion Index for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Tanta, 이집트
- Tanta University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult patients of both sexes (aged 21- 65 years)
- patients with American Society of Anesthesiologists physical status I or II scheduled for elective shoulder arthroscopy in beach chair position under general anesthesia.
Exclusion Criteria:
- Patient's refusal
- Patients with suspected difficult airway
- Patients with preexisting hypertension, diabetes mellitus, cardiovascular, cerebrovascular and peripheral vascular diseases
- Patients with preoperative hypotension (mean arterial blood pressure < 65 mmHg).
- Patients with preexisting renal or hepatic impairment.
- Pregnancy 8. Patients with increased intra-abdominal pressure 9. Patients with post induction hypotension
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Group I
70 adult patients of both sexes (aged 21- 65 years) with American Society of Anesthesiologists physical status I or II scheduled for elective shoulder arthroscopy in beach chair position under general anesthesia.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The accuracy of Peripheral Perfusion Index for predicting hypotension
기간: pre induction of General anesthesia
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The Peripheral Perfusion Index will be measured using a pulse oximetry probe attached to the index finger of the non-operable hand
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pre induction of General anesthesia
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2차 결과 측정
결과 측정 |
기간 |
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Incidence of hypotension
기간: 30 minutes Intraoperatively
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30 minutes Intraoperatively
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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. .