Predictive Value of Combined RSBI, TOF, and BIS Monitoring for Extubation Success After General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究者
Muhammed Gökhan Abay
Specialist Physician in Anesthesiology and Reanimation
Gaziantep City Hospital
