Combined RSBI, TOF, and BIS for Prediction of Extubation Success

NCT07577453 | Not Yet Recruiting

• 1 other identifier: 127
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Extubation Failure; Extubation Success; Postoperative Respiratory Complications

Keywords

Extubation; Extubation Succcess; Extubation failure; General anesthesia; Rapid shallow breathing index; TOF ratio; Bispectral index; Neuromuscular monitoring; Postoperative respiratory complications; Prediction model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Predictive performance of rapid shallow breathing index alone for successful extubation

  From immediately before extubation to 30 minutes after extubation

• Predictive performance of train-of-four ratio alone for successful extubation

  From immediately before extubation to 30 minutes after extubation

• Predictive performance of bispectral index alone for successful extubation

  From immediately before extubation to 30 minutes after extubation

• Comparison of the predictive performance of the combined model with single-parameter models

  From immediately before extubation to 30 minutes after extubation

• Incidence of problematic extubation

  Within 30 minutes after extubation

Study Arms (1)

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

Interventions

Combined pre-extubation assessment using RSBI, TOF ratio, and BIS OTHER

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.

Patients Undergoing Extubation After General Anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Central Study Contacts

Muhammed Gökhan Abay, MD

CONTACT

+905379479745; abay.25@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician in Anesthesiology and Reanimation

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 11, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share