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

NCT07722897 | Recruiting

• 1 other identifier: AkdenizUH1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness

Keywords

Rapid Sequence Intubation; Emergency Department; Bispectral Index; Hemodynamic Response

Outcome Measures

Primary Outcomes (3)

• Change in Diastolic Blood Pressure Following Rapid Sequence 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

  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

  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

Study Arms (1)

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.

Device: Bispectral Index (BIS) Monitoring

Interventions

Bispectral Index (BIS) Monitoring DEVICE

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.

Emergency Department Patients Undergoing Rapid Sequence Intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University Hospital: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07059, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Forbes AM, Dally FG. Acute hypertension during induction of anaesthesia and endotracheal intubation in normotensive man. Br J Anaesth. 1970 Jul;42(7):618-24. doi: 10.1093/bja/42.7.618. No abstract available.

  PMID: 5453244 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erkan Göksu, MD

CONTACT

+905054691764; erkangoksu@akdeniz.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)