Combined RSBI, TOF, and BIS for Prediction of Extubation Success
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGaziantep City Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Emergency surgery
Age <18 years or >80 years
ASA physical status IV or higher
Known or anticipated difficult airway
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Combined pre-extubation assessment using RSBI, TOF ratio, and BIS
Other interventionRSBI, 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Patients Undergoing Extubation After General Anesthesia1 intervention
Trial outcomes
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.
Time frame
From immediately before extubation to 30 minutes after extubationSecondary outcomes
1
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.
Time frame
From immediately before extubation to 30 minutes after extubation2
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.
Time frame
From immediately before extubation to 30 minutes after extubation3
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.
Time frame
From immediately before extubation to 30 minutes after extubation4
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.
Time frame
From immediately before extubation to 30 minutes after extubationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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