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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Muhammed Gökhan Abay, MD contact

+905379479745

abay.25@gmail.com

Turkey (Türkiye)1 site
  • Gaziantep City Hospital

    Gaziantep

    Muhammed Gökhan Abay, +905379479745, Abay.25@gmail.com

Other trials in Turkey (Türkiye)

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 groups in NCT07577453
Study groupRoleWhat they receive
Patients Undergoing Extubation After General AnesthesiaAdult 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.

  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.

    Measured: From immediately before extubation to 30 minutes after extubation

Secondary outcomes (7)
  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.

    Measured: From immediately before extubation to 30 minutes after extubation

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted11 May 2026
  2. Study start10 Oct 2026 (estimated)
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

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)
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

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.

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