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- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Pavo, 34093
- Istanbul University, Department of anesthesiology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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 activo: 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 activo: 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 activo: McGrath videolaryngoscope
Endotracheal intubation with McGrath videolaryngoscope
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Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Arterial blood pressure
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of intubation attempts
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: During endotracheal intubation
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Cormack-Lehane scales were recorded
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During endotracheal intubation
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Complications
Periodo de tiempo: During endotracheal intubation
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Possible complications were recorded
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During endotracheal intubation
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Sore throat
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2014/1191
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