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Non-invasive Perioperative Hb Monitoring in Spinal Surgery

18 de abril de 2018 atualizado por: Tehran University of Medical Sciences

Evaluating and Comparing the Accuracy of Non-invasive Hemoglobin Monitoring by Spectrophotometry With and Without Digital Nerve Block in Patients Undergoing Spinal Surgery in Sina Hospital During 2016-2017

The decision to transfuse or not to transfuse blood products is one of the main issues in patients undergoing surgery.

The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent data, and requires venipuncture which is invasive and painful. In the past decade, the use of non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the patient's bedside, have become widespread. One of the tools that make this possible is Spectrophotometric Hemoglobin.

However, one of the main concerns regarding this method is its accuracy. Since the accuracy of this assessment depends on the extent of perfusion of the organ on which the probe is placed, use of digital nerve blocks proposed to increase its accuracy.

This study aims to evaluate the effects of digital nerve block (with bupivacaine) on the accuracy of non-invasive hemoglobin monitoring by spectrophotometry in patients undergoing spinal surgery.

Visão geral do estudo

Status

Concluído

Descrição detalhada

The decision to transfuse or not to transfuse blood products is one of the main issues in healthcare systems. Timely transfusion of blood to a patient bleeding, either due to the surgery or because of the trauma, can prevent tissue hypoxia and ischemia in vital organs. However, transfusion of blood products should be done carefully and cautiously due to the potential complications of transfusions, and also because of the cost of providing blood products 1, 2, 3. Hence, during surgeries, hemoglobin level has a vital role in the diagnosis and management of patients with anemia.

The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent data, and requires venipuncture which is invasive and painful. In the past decade, the use of non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the patient's bedside, have become widespread. One of the tools that make this possible is Spectrophotometric Hemoglobin (SpHb Masimo Rainbow Co-oximeter). This procedure is applied by a digital probe and allows physicians to monitor hemoglobin levels continuously. 4, 5, 6 However, one of the main concerns regarding this method is its accuracy. Actually, the difference between the measured hemoglobin level and the actual hemoglobin level of the patient, might make it impossible for physicians to decide with sufficient confidence3.

From the time that SpHb has been available in operating rooms, various studies have evaluated its accuracy. While its accuracy has been reported relatively acceptable (mean difference is about 1-1.5 g/dl comparing to the lab data),4 there are still concerns regarding this issue. Furthermore, it is not clear whether this difference would remain the same during the surgery or not. Because blood transfusion is rarely needed when the hemoglobin level of patient is higher than 10g/dl during the surgery. Also, blood transfusion becomes obviously necessary if hemoglobin levels drop to 6g/dl or lower during the surgery. Therefore, the accuracy of the tool in assessing hemoglobin levels at this critical interval (6-10g/dl) is of greater importance.6,7 Experimental studies have confirmed that accuracy could change in different hemoglobin levels5,8, and with the passage of time.9 In addition, it has been reported that after significant blood loss or even following injection of blood, the average difference between SpHb and laboratory might change, as well. 5,8 Since the accuracy of this assessment depends on the extent of perfusion of the organ on which the probe is placed, methods that enhance blood circulation in the organ (including local heating of the organ and use of digital nerve blocks (DNB), proposed to increase its accuracy.10, 11 In a study conducted in 2012 by Miller et al. on 20 patients undergoing spinal surgery, DNB was performed using lidocaine. The differences between SpHb and lab hemoglobin were recorded first after injection, and then at almost hourly intervals. These differences were compared to data from another study without DNB. Thirty seven percent of data in the intervention group and 12% of data in the control group was considered as "very accurate". Results of this study showed that DNB increased perfusion indices and SpHb accuracy.10 Following the previous study, Miller et al. carried out a study in 2014 to compare the effects of DNB with lidocaine and bupivacaine on 12 healthy volunteers. DNB was performed on two identical fingers on both hands of the volunteers. Lidocaine was used on one hand and bupivacaine on the other one. Results of this study showed that both lidocaine and bupivacaine raised the perfusion indices and temperatures of the fingers. The duration and extent of the rise in temperature were more for bupivacaine, and there was a direct correlation between changes in perfusion index and those in SpHb.11 Since, the previous study data had been gathered from healthy individuals, this study aims at investigate the effects of DNB on the accuracy SpHb in patients undergoing surgery.

Tipo de estudo

Intervencional

Inscrição (Real)

23

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria: All patients 18 years of age or older, admitted to Sina hospital to have spinal surgery, whose surgery is not an emergency, are included in the study. Moreover, the patients must be in grade 2 or lower according to the ASA Physical Status Classification, and volunteer to participate in the study.

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Exclusion Criteria: Patients who are going to have an emergency surgery are excluded from the study. Also patients with grade 3 ASA or higher, or the ones suffering from anatomic or vascular disorders that cause problems in attaching the SpHb sensor, are excluded from the study.

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Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Digital nerve block in left hand
Patients in this group will receive DNB in left hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).
The aim of the study, the way it will be conducted, and the complications and possible risks are explained to them. written informed consent is obtained from them. Then, after induction of anaesthesia, an arterial line will be inserted in order to monitor blood pressure and to take blood samples. During the surgery, two rainbow adult ReSposable sensors will be attached to the third or fourth fingers of both hands, and each of sensors will be attached to a monitor. Patients will be randomly assigned to two groups: group A will receive DNB in left hand and group B will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).
Experimental: Digital nerve block in right hand
Patients in this group will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).
The aim of the study, the way it will be conducted, and the complications and possible risks are explained to them. written informed consent is obtained from them. Then, after induction of anaesthesia, an arterial line will be inserted in order to monitor blood pressure and to take blood samples. During the surgery, two rainbow adult ReSposable sensors will be attached to the third or fourth fingers of both hands, and each of sensors will be attached to a monitor. Patients will be randomly assigned to two groups: group A will receive DNB in left hand and group B will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
accuracy of SpHb
Prazo: At the start of the operation, once every 1.5 hours during the operation till its end
in each patient, Sphb values will be documented for both hands. Also, the arterial blood sample (lab Hb) will be sent to the laboratory. The difference between two measure in each hand (with or without DNB) shows the accuracy of Sphb for each hand.
At the start of the operation, once every 1.5 hours during the operation till its end

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Perfusion index (PI)
Prazo: At the start of the operation, once every 1.5 hours during the operation till its end
In each patient, PI value of hand with DNB will be compared to PI measure in the other hand.
At the start of the operation, once every 1.5 hours during the operation till its end
Pleth Variability Index (PVI)
Prazo: At the start of the operation, once every 1.5 hours during the operation till its end
In each patient, PVI value of hand with DNB will be compared to PI measure in the other hand.
At the start of the operation, once every 1.5 hours during the operation till its end

Colaboradores e Investigadores

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Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de janeiro de 2017

Conclusão Primária (Real)

1 de outubro de 2017

Conclusão do estudo (Real)

1 de janeiro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

15 de setembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de setembro de 2016

Primeira postagem (Estimativa)

21 de setembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de abril de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de abril de 2018

Última verificação

1 de dezembro de 2017

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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