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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07722897
Enrollment
200
Registered
2026-07-23
Start date
2026-05-01
Completion date
2028-05-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

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

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.

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.

Interventions

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.

Sponsors

Akdeniz University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Change in Diastolic Blood Pressure Following Rapid Sequence IntubationBaseline, immediately after intubation, and 5, 10, and 15 minutes after intubationDiastolic 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.
Change in Systolic Blood Pressure Following Rapid Sequence IntubationBaseline, immediately after intubation, and 5, 10, and 15 minutes after intubationSystolic 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.
Change in Heart Rate Following Rapid Sequence IntubationBaseline, immediately after intubation, and 5, 10, and 15 minutes after intubationHeart 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTErkan Göksu, MD
erkangoksu@akdeniz.edu.tr+905054691764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026