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- Ensaio Clínico NCT02469363
Hemodynamic Responses of Different Laryngoscopes
Comparison of Different Laryngoscopes in Terms of Hemodynamic Responses
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and techniques have recently started to be used.
In this randomized single blind study, the aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.
Visão geral do estudo
Status
Descrição detalhada
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and methods have recently started to be used.
In this randomized single blind study, our aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.
After obtaining Institutional Ethics Committee approval and patient consents, 170 patients (18-65 years old) with ASA I-II status requiring general anesthesia with endotracheal intubation, were enrolled to this prospective randomized study.
Besides routine monitorization (noninvasive blood pressure (NIBP), electrocardiography (ECG), heart rate (HR), peripheral oxygen saturation (SPO2)), continuous BIS monitorization was also performed. Sedation was performed using a standard dose of IV fentanyl (1.5 μg/kg) and midazolam (0.05 mg/kg). Baseline systolic, diastolic and mean arterial blood pressures, HR and SPO2 values were recorded as T0. After a stabilization period of 10 minutes, propofol 2-3 mg/kg IV bolus was applied incrementally until a clinically desirable sedation level was achieved. If necessary, additional propofol boluses were given to maintain a BIS level of 60. As soon as BIS level was reduced to 60, patients were put on 0.6 mg/kg IV rocuronium. 100% oxygen was applied with a facemask for a period of 3 minutes. Then, post induction values (T1) were recorded.
One hundred seventy patients were randomly allocated equally to Macintosh laryngoscope, Mc-Coy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope groups. Endotracheal tube (ETT) of 7.0 mm and 7.5 mm were placed to female and male patients, respectively. All intubation procedures were performed by a single experienced anesthesiologist. Intubation stylet was provided, if necessary. Cuff pressures of endotracheal tubes were standartized to 30 cmH2O via a manometer. The following measurements were recorded immediately after intubation (T2) and at one minute intervals for 5 minutes (T3, T4, T5, T6 and T7).
Moreover; the number of intubation attempts, stylet needs, Cormack-Lehane scales, and the complications occurred during intubation procedures were recorded as the second outcomes. Patients were also questioned for possible sore throat at postoperative 2 hours. Patients requiring more than one attempt to achieve successful intubation were excluded from statistical analysis of data.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Istanbul, Peru, 34093
- Istanbul University, Department of anesthesiology
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients with ASA I-II status, requiring general anesthesia with endotracheal intubation
Exclusion Criteria:
- ASA status higher than II, a history or suspected of difficult airway, hypertansion, under treatment known to affect blood pressure or heart rate (Beta blocker/ Ca-channel blocker), BIS value > 60
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Macintosh laryngoscope
Endotracheal intubation with classic (Macintosh) laryngoscope
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Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
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Comparador Ativo: Mc-Coy laryngoscope
Endotracheal intubation with Mc-Coy laryngoscope
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Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
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Comparador Ativo: C-Mac videolaryngoscope
Endotracheal intubation with C-Mac videolaryngoscope
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Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
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Comparador Ativo: McGrath videolaryngoscope
Endotracheal intubation with McGrath videolaryngoscope
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Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope
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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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Arterial blood pressure
Prazo: Change from baseline in blood pressures at first 20 minutes
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Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded during and after induction
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Change from baseline in blood pressures at first 20 minutes
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Heart rate
Prazo: Change from baseline in heart rates at first 20 minutes
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Hemodynamic parameters as heart rates were recorded during and after induction
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Change from baseline in heart rates at first 20 minutes
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SPO2 value
Prazo: Change from baseline in SPO2 values at first 20 minutes
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Hemodynamic parameters as SPO2 values were recorded during and after induction
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Change from baseline in SPO2 values at first 20 minutes
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of intubation attempts
Prazo: During endotracheal intubation
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Number of intubation attempts were recorded
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During endotracheal intubation
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Stylet need
Prazo: During endotracheal intubation
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Stylet need was recorded
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During endotracheal intubation
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Cormach-Lehane scales
Prazo: During endotracheal intubation
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Cormack-Lehane scales were recorded
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During endotracheal intubation
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Complications
Prazo: During endotracheal intubation
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Possible complications were recorded
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During endotracheal intubation
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Sore throat
Prazo: Postoperative 2 hours
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Possible sore throat was recorded
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Postoperative 2 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Demet Altun, MD, Istanbul University, Department of Anesthesiology an Reanimation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- 2014/1191
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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