Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department

July 20, 2026 updated by: Erkan Göksu, Akdeniz University Hospital

Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.

Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.

The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.

Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.

The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years) requiring rapid sequence intubation (RSI) in the emergency department for airway management. All eligible patients underwent bispectral index (BIS) monitoring before laryngoscopy, and hemodynamic responses were evaluated after confirmation of adequate depth of anesthesia.

Description

Inclusion Criteria:

Adults aged 18 years or older. Patients undergoing rapid sequence intubation (RSI) in the emergency department.

Patients in whom bispectral index (BIS) monitoring can be applied before laryngoscopy.

Patients achieving an adequate depth of anesthesia (BIS 45-55) before laryngoscopy.

Written informed consent obtained from the patient or a legally authorized representative, when applicable according to local ethics requirements.

Exclusion Criteria:

Age <18 years. Cardiac arrest before or during induction. Patients requiring immediate ("crash") intubation without sufficient time for BIS monitoring.

Inability to obtain reliable BIS monitoring (e.g., technical failure or inability to place the sensor).

Pregnancy. Facial or scalp conditions preventing BIS sensor placement. Prisoners or other vulnerable populations if excluded by the ethics protocol.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emergency Department Patients Undergoing Rapid Sequence Intubation
Adult patients undergoing rapid sequence intubation in the emergency department. Bispectral index (BIS) monitoring is used to confirm adequate depth of anesthesia before laryngoscopy. Hemodynamic parameters are recorded before, during, and after endotracheal intubation.
Bispectral index monitoring is used to assess the depth of anesthesia before laryngoscopy. Endotracheal intubation is performed after an adequate BIS value has been achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diastolic Blood Pressure Following Rapid Sequence Intubation
Time Frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Diastolic Blood pressure (MAP) measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Change in Systolic Blood Pressure Following Rapid Sequence Intubation
Time Frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Systolic Blood pressure measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Change in Heart Rate Following Rapid Sequence Intubation
Time Frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Heart Rate measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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