- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07722897
Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Erkan Göksu, MD
- Phone Number: +905054691764
- Email: erkangoksu@akdeniz.edu.tr
Study Locations
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-
-
Antalya, Turkey (Türkiye), 07059
- Recruiting
- Akdeniz University Hospital
-
Contact:
- Erkan Göksu, MD
- Phone Number: 05054691764
- Email: erkangoksu@akdeniz.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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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.
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Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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Change in Systolic Blood Pressure Following Rapid Sequence Intubation
Time Frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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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.
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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.
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Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AkdenizUH1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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