- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Erkan Göksu, MD
- Telefonnummer: +905054691764
- E-post: erkangoksu@akdeniz.edu.tr
Studiesteder
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Antalya, Tyrkia (Türkiye), 07059
- Rekruttering
- Akdeniz University Hospital
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Ta kontakt med:
- Erkan Göksu, MD
- Telefonnummer: 05054691764
- E-post: erkangoksu@akdeniz.edu.tr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Diastolic Blood Pressure Following Rapid Sequence Intubation
Tidsramme: 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
Tidsramme: 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
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Change in Heart Rate Following Rapid Sequence Intubation
Tidsramme: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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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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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AkdenizUH1
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