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Recruiting NCT07722897

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

Observational Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bispectral Index (BIS) Monitoring.
Who it may be relevant to
Registry conditions: Critical Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Device Bispectral Index (BIS) Monitoring
    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.

Primary outcome measures

  • Change in Diastolic Blood Pressure Following Rapid Sequence Intubation [Time frame: 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]
  • Change in Heart Rate Following Rapid Sequence Intubation [Time frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation]

Eligibility criteria

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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Akdeniz University Hospital — Antalya

Publications

  • 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

Identifiers

NCT: NCT07722897 · AkdenizUH1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗