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

20 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

200

Kontakter och platser

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Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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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Studieplan

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Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Diastolic Blood Pressure Following Rapid Sequence Intubation
Tidsram: 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
Tidsram: 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
Tidsram: 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

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Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

1 maj 2028

Avslutad studie (Beräknad)

1 maj 2028

Studieregistreringsdatum

Först inskickad

20 juli 2026

Först inskickad som uppfyllde QC-kriterierna

20 juli 2026

Första postat (Faktisk)

23 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

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Studerar en amerikansk FDA-reglerad produktprodukt

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