- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07577453
Combined RSBI, TOF, and BIS for Prediction of Extubation Success
Predictive Value of Combined RSBI, TOF, and BIS Monitoring for Extubation Success After General Anesthesia
This prospective observational study aims to evaluate the predictive value of the combined use of the rapid shallow breathing index, train-of-four ratio, and bispectral index for extubation success after general anesthesia. Adult patients undergoing elective surgery under general anesthesia and planned for extubation in the operating room will be included.
Before extubation, RSBI, TOF ratio, BIS value, respiratory parameters, and relevant perioperative data will be recorded. The decision to extubate will be made by the attending anesthesiologist according to routine clinical practice and will not be altered by the study protocol. Patients will be followed for 30 minutes after extubation to assess extubation success or the development of complications such as desaturation, laryngospasm, need for airway intervention, mask ventilation, or reintubation.
The primary aim is to determine whether the combined RSBI, TOF, and BIS model predicts extubation success more accurately than each parameter alone.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Safe extubation after general anesthesia requires adequate recovery in several physiological domains, including consciousness, neuromuscular function, and spontaneous ventilation. In routine anesthetic practice, extubation is rarely based on a single variable. Instead, clinicians integrate multiple clinical and monitor-based findings before deciding whether a patient is ready for tracheal extubation.
The bispectral index, train-of-four ratio, and rapid shallow breathing index represent three different components of extubation readiness. BIS reflects the depth of anesthesia and recovery of consciousness, TOF ratio indicates the degree of neuromuscular recovery, and RSBI reflects the adequacy of spontaneous breathing pattern. Although each of these parameters may provide useful information, their combined evaluation may offer a more comprehensive prediction of extubation success.
This prospective observational cohort study will include adult patients undergoing elective surgery under general anesthesia who are planned for extubation in the operating room. The study will be conducted without changing the standard anesthetic management. No randomization or study-related therapeutic intervention will be performed. The final decision to extubate will be made by the attending anesthesiologist according to routine clinical practice and will not be altered by the study protocol.
Pre-extubation data will include demographic variables, ASA physical status, body mass index, type and duration of surgery, anesthetic duration, neuromuscular blocking agent use, reversal agent use, respiratory rate, tidal volume, RSBI, TOF ratio, BIS value, peripheral oxygen saturation, and end-tidal carbon dioxide. RSBI will be calculated as respiratory rate divided by tidal volume in liters. TOF ratio and BIS values will be measured immediately before extubation.
Following extubation, patients will be monitored for 30 minutes for extubation-related respiratory or airway events. Successful extubation will be defined as the absence of reintubation, need for assisted mask ventilation, severe desaturation, laryngospasm, clinically significant respiratory distress, or other airway intervention within 30 minutes after extubation. Problematic extubation will be defined as the presence of any of these events.
The primary outcome of this study is the predictive performance of the combined RSBI, TOF ratio, and BIS model for successful extubation. Secondary outcomes include the individual predictive performance of RSBI, TOF ratio, and BIS; comparison of the combined model with each single-parameter model; extubation time; and the incidence of extubation-related complications such as desaturation, coughing, agitation, laryngospasm, need for airway intervention, assisted ventilation, and reintubation.
The main hypothesis is that the combined evaluation of RSBI, TOF ratio, and BIS provides superior predictive performance for extubation success compared with RSBI, TOF ratio, or BIS alone. Statistical analysis will include comparison of patients with successful and problematic extubation, receiver operating characteristic curve analysis for each parameter, and logistic regression analysis for the combined model. The area under the curve values of the single-parameter models and the combined model will be compared.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammed Gökhan Abay, MD
- Número de teléfono: +905379479745
- Correo electrónico: abay.25@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age between 18 and 80 years
- ASA physical status I-III
- Patients scheduled for elective surgery under general anesthesia
- Patients undergoing endotracheal intubation during general anesthesia
- Patients receiving neuromuscular blocking agents during anesthesia
- Patients planned for extubation in the operating room
- Availability of pre-extubation RSBI, TOF ratio, and BIS measurements
- Written informed consent obtained from the patient
Exclusion Criteria:
- Emergency surgery
- Age <18 years or >80 years
- ASA physical status IV or higher
- Known or anticipated difficult airway
- Anticipated difficult extubation
- Preoperative mechanical ventilation
- Planned postoperative mechanical ventilation or transfer to the intensive care unit while intubated
- Known neuromuscular disease
- Severe chronic respiratory failure
- Severe chronic obstructive pulmonary disease associated with respiratory failure
- Significant neurological disease affecting respiratory drive or level of consciousness
- Conditions or medications that may interfere with reliable neuromuscular monitoring
- Inability to obtain reliable RSBI, TOF ratio, or BIS measurements
- Refusal to participate
- Incomplete perioperative or post-extubation outcome data
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Patients Undergoing Extubation After General Anesthesia
Adult patients undergoing elective surgery under general anesthesia who are planned for extubation in the operating room will be prospectively observed.
Before extubation, RSBI, TOF ratio, and BIS values will be recorded.
The decision to extubate will be made by the attending anesthesiologist according to routine clinical practice and will not be altered by the study protocol.
|
RSBI, TOF ratio, and BIS values will be recorded immediately before extubation as part of the study assessment.
RSBI will be calculated using respiratory rate and tidal volume.
TOF ratio will be used to assess neuromuscular recovery, and BIS will be used to assess the level of consciousness.
These measurements will be evaluated for their predictive value for extubation success.
The study protocol will not determine or alter the extubation decision.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Predictive performance of the combined RSBI, TOF ratio, and BIS model for successful extubation
Periodo de tiempo: From immediately before extubation to 30 minutes after extubation
|
The primary outcome will be the predictive performance of the combined model including rapid shallow breathing index, train-of-four ratio, and bispectral index for successful extubation after general anesthesia.
Successful extubation will be defined as the absence of reintubation, need for assisted mask ventilation, severe desaturation, laryngospasm, clinically significant respiratory distress, or other airway intervention within 30 minutes after extubation.
The predictive performance of the combined model will be evaluated using receiver operating characteristic curve analysis and the area under the curve.
|
From immediately before extubation to 30 minutes after extubation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Predictive performance of rapid shallow breathing index alone for successful extubation
Periodo de tiempo: From immediately before extubation to 30 minutes after extubation
|
The predictive value of pre-extubation RSBI alone for successful extubation will be evaluated.
RSBI will be calculated as respiratory rate divided by tidal volume in liters.
Receiver operating characteristic curve analysis will be performed, and the area under the curve will be calculated.
|
From immediately before extubation to 30 minutes after extubation
|
|
Predictive performance of train-of-four ratio alone for successful extubation
Periodo de tiempo: From immediately before extubation to 30 minutes after extubation
|
The predictive value of pre-extubation TOF ratio alone for successful extubation will be evaluated.
TOF ratio will be recorded immediately before extubation.
Receiver operating characteristic curve analysis will be performed, and the area under the curve will be calculated.
|
From immediately before extubation to 30 minutes after extubation
|
|
Predictive performance of bispectral index alone for successful extubation
Periodo de tiempo: From immediately before extubation to 30 minutes after extubation
|
The predictive value of pre-extubation BIS alone for successful extubation will be evaluated.
BIS value will be recorded immediately before extubation.
Receiver operating characteristic curve analysis will be performed, and the area under the curve will be calculated.
|
From immediately before extubation to 30 minutes after extubation
|
|
Comparison of the predictive performance of the combined model with single-parameter models
Periodo de tiempo: From immediately before extubation to 30 minutes after extubation
|
The area under the curve of the combined RSBI, TOF ratio, and BIS model will be compared with the area under the curve values of RSBI, TOF ratio, and BIS individually to determine whether the combined model provides superior predictive performance.
|
From immediately before extubation to 30 minutes after extubation
|
|
Incidence of problematic extubation
Periodo de tiempo: Within 30 minutes after extubation
|
Problematic extubation will be defined as the occurrence of any of the following within 30 minutes after extubation: severe desaturation, clinically significant respiratory distress, laryngospasm, need for airway intervention, need for assisted mask ventilation, or reintubation.
|
Within 30 minutes after extubation
|
|
Incidence of post-extubation desaturation
Periodo de tiempo: Within 30 minutes after extubation
|
Post-extubation desaturation will be defined as peripheral oxygen saturation below 92% within 30 minutes after extubation.
|
Within 30 minutes after extubation
|
|
Number of Participants Requiring Airway Intervention Within 30 Minutes After Extubation
Periodo de tiempo: Within 30 minutes after extubation
|
The number of participants requiring any airway intervention within 30 minutes after extubation will be recorded.
Airway interventions include airway repositioning, jaw thrust maneuver, oral or nasal airway insertion, assisted mask ventilation, or reintubation.
|
Within 30 minutes after extubation
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 127 (Tumor Vaccine Group)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .