Combined RSBI, TOF, and BIS for Prediction of Extubation Success (NCT07577453) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Combined RSBI, TOF, and BIS for Prediction of Extubation Success
150 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive performance of the combined RSBI, TOF ratio, and BIS model for successful extubation
Timeframe: From immediately before extubation to 30 minutes after extubation