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

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record status
This record was last updated May 13, 2026 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints revised (7)v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07577453
Lead Sponsor Gaziantep City Hospital
Conditions
(from sponsor)		 Extubation Success, Extubation Failure, Postoperative Respiratory Complications
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov