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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Respiratory Complications; Extubation Failure; Extubation Success
• Intervention / Treatment: Other: Combined pre-extubation assessment using RSBI, TOF ratio, and BIS

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Muhammed Gökhan Abay, MD; Phone Number: +905379479745; Email: abay.25@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective surgery under general anesthesia with endotracheal intubation and planned extubation in the operating room will be prospectively enrolled. Patients will be included if pre-extubation RSBI, TOF ratio, and BIS measurements can be obtained and if they provide written informed consent.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Combined pre-extubation assessment using RSBI, TOF ratio, and BIS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive performance of the combined RSBI, TOF ratio, and BIS model for successful 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive performance of rapid shallow breathing index alone for successful 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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Gaziantep City Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bispectral index; Extubation; Prediction model; General anesthesia; Extubation failure; Rapid shallow breathing index; Postoperative respiratory complications; Neuromuscular monitoring; TOF ratio; Extubation Succcess
• Other Study ID Numbers: 127 (Tumor Vaccine Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No