Extubation SuccessNCT07577453
Combined RSBI, TOF, and BIS for Prediction of Extubation Success
An observational study of Extubation Success and Extubation Failure, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Extubation Success, Extubation Failure, Postoperative Respiratory Complications
- What is being tested?
- Combined pre-extubation assessment using RSBI, TOF ratio, and BIS
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2026to 15 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziantep City Hospital
Gaziantep
Muhammed Gökhan Abay, +905379479745, Abay.25@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Combined pre-extubation assessment using RSBI, TOF ratio, and BIS
- Keywords
- Extubation, Extubation Succcess, Extubation failure, General anesthesia, Rapid shallow breathing index, TOF ratio, Bispectral index, Neuromuscular monitoring, Postoperative respiratory complications, Prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined pre-extubation assessment using RSBI, TOF ratio, and BISOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Combined pre-extubation assessment using RSBI, TOF ratio, and BIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From immediately before extubation to 30 minutes after extubation
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start10 Oct 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation SuccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Gökhan Abay, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577453
- Sponsor's protocol ID
- 127
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Combined RSBI, TOF, and BIS Monitoring for Extubation Success After General Anesthesia
- ClinicalTrials.gov ID
- NCT07577453
- Acronym / sponsor ID
- 127
- Keywords
- Extubation, Extubation Succcess, Extubation failure, General anesthesia, Rapid shallow breathing index, TOF ratio, Bispectral index, Neuromuscular monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Extubation After General Anesthesia | – | Other: Combined pre-extubation assessment using RSBI, TOF ratio, and BISAdult 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- Emergency surgery
- Age <18 years or >80 years
- ASA physical status IV or higher
- Known or anticipated difficult airway
- Anticipated difficult extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined pre-extubation assessment using RSBI, TOF ratio, and BISRSBI, 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. | Other | Patients Undergoing Extubation After General Anesthesia |
Primary outcome
Predictive performance of the combined RSBI, TOF ratio, and BIS model for successful extubation
Time frame: From immediately before extubation to 30 minutes after 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.
7 secondary outcomes
Predictive performance of rapid shallow breathing index alone for successful extubation
Time frame: From immediately before extubation to 30 minutes after extubation
Predictive performance of train-of-four ratio alone for successful extubation
Time frame: From immediately before extubation to 30 minutes after extubation
Predictive performance of bispectral index alone for successful extubation
Time frame: From immediately before extubation to 30 minutes after extubation
Comparison of the predictive performance of the combined model with single-parameter models
Time frame: From immediately before extubation to 30 minutes after extubation
Incidence of problematic extubation
Time frame: Within 30 minutes after extubation
Number of Participants Requiring Airway Intervention Within 30 Minutes After Extubation
Time frame: Within 30 minutes after extubation
Incidence of post-extubation desaturation
Time frame: Within 30 minutes after extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Extubation Success
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
A Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients With or Without High Velocity Nasal Insufflation
High Velocity Nasal Insufflation, Simple Oxygen
Not yet recruitingObservational study
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
Ventilator Weaning, Respiratory Insufficiency
Not yet recruitingObservational study
Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing
Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded
Not yet recruiting
Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Patients
Respiratory Muscle Weakness, Mechanical Ventilation Weaning
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation Success and Extubation Failure, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Gökhan Abay, MD (+905379479745, abay.25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of the combined RSBI, TOF ratio, and BIS model for successful extubation (time frame: From immediately before extubation to 30 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.