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- Ensaio Clínico 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.
Visão geral do estudo
Status
Descrição detalhada
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
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Tanta, Egito
- Tanta University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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The accuracy of Peripheral Perfusion Index for predicting hypotension
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Incidence of hypotension
Prazo: 30 minutes Intraoperatively
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30 minutes Intraoperatively
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 36264MS884/3/25
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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