- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Erkan Göksu, MD
- Telefonní číslo: +905054691764
- E-mail: erkangoksu@akdeniz.edu.tr
Studijní místa
-
-
-
Antalya, Turecko (Türkiye), 07059
- Nábor
- Akdeniz University Hospital
-
Kontakt:
- Erkan Göksu, MD
- Telefonní číslo: 05054691764
- E-mail: erkangoksu@akdeniz.edu.tr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
-
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Diastolic Blood Pressure Following Rapid Sequence Intubation
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AkdenizUH1
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Závažné onemocnění
Klinické studie na Bispectral Index (BIS) Monitoring
-
University Hospital OstravaMunicipal Hospital Ostrava; Tomas Bata Hospital, Czech Republic; Frýdek-Místek... a další spolupracovníciZatím nenabíráme
-
University of Medicine and Dentistry of New JerseyUkončenoBolest, pooperační
-
Marmara UniversityNáborPectus Excavatum | Deformace hrudníkuTurecko (Türkiye)
-
University Medical Centre LjubljanaDokončeno
-
Vanderbilt University Medical CenterMedtronic - MITGDokončenoDelirium | Kognitivní porucha | Kriticky nemocnýSpojené státy
-
Marmara UniversityNáborLumbální spinální stenóza | Degenerace bederních disků | Bederní degenerativní spondylolistéza | Lumbální disk hernie s radikulopatiíTurecko (Türkiye)
-
Sameh FathyDokončeno