- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07690254
Bispectral Index and First-Pass Intubation
Evaluation of First-Pass Endotracheal Intubation Success Using the Bispectral Index in Patients Undergoing Endotracheal Intubation in the Emergency Department
This prospective observational study aims to evaluate the association between anesthetic depth, measured by the Bispectral Index (BIS), and first-pass endotracheal intubation success in adult patients undergoing rapid sequence intubation (RSI) in the emergency department.
Endotracheal intubation is one of the most critical procedures performed in emergency medicine. Multiple intubation attempts are associated with an increased risk of adverse events, including hypoxemia, aspiration, cardiovascular complications, and death. Although several factors influence first-pass intubation success, the contribution of anesthetic depth at the time of intubation has not been adequately investigated in the emergency department.
Patients for whom the treating emergency physician decides to perform RSI will undergo noninvasive BIS monitoring using a disposable forehead sensor. The physician performing the intubation will remain blinded to the BIS value throughout the procedure and will perform intubation according to routine clinical practice. A separate investigator, who is not involved in patient management, will record the BIS value at the time of intubation.
The BIS measurements will not be disclosed to the treating team and will not influence clinical decision-making, medication dosing, or patient management. The study is purely observational and does not evaluate the performance or effectiveness of the BIS device itself.
The primary objective is to determine whether patients who achieve first-pass intubation success differ in anesthetic depth from those requiring multiple intubation attempts.
Přehled studie
Postavení
Podmínky
Detailní popis
Endotracheal intubation is a life-saving intervention frequently performed in the emergency department for patients with airway compromise, respiratory failure, or critical illness. Despite its importance, emergency airway management is associated with a substantial risk of adverse events. Previous studies have consistently demonstrated that multiple intubation attempts significantly increase the likelihood of hypoxemia, aspiration, hypotension, cardiac arrest, airway trauma, and mortality. Therefore, achieving first-pass success has become one of the principal quality indicators in emergency airway management.
Several patient-, operator-, and procedure-related factors influence first-pass success, including anatomical difficulty, operator experience, type of laryngoscope, choice of sedative and neuromuscular blocking agents, and optimization of preoxygenation. Another potentially important but understudied factor is the depth of anesthesia at the moment of laryngoscopy and intubation.
Adequate anesthetic depth before laryngoscopy suppresses airway reflexes, minimizes patient movement, and improves intubating conditions. Previous studies comparing succinylcholine and rocuronium have suggested differences in intubation conditions; however, subsequent investigations demonstrated that these differences were largely attributable to dosing strategies rather than the neuromuscular blocking agent itself. Current evidence indicates that when appropriate doses are administered, both agents provide comparable intubating conditions. Nevertheless, regardless of the neuromuscular blocking agent used, insufficient hypnotic depth may adversely affect intubation conditions.
The Bispectral Index (BIS) is a processed electroencephalographic parameter ranging from 0 to 100 that provides an objective assessment of the patient's level of consciousness. BIS monitoring has been extensively validated in the operating room and has demonstrated a strong correlation with anesthetic depth. Randomized clinical trials have shown that BIS-guided anesthesia reduces the incidence of intraoperative awareness and may facilitate individualized anesthetic administration. However, BIS monitoring is not routinely incorporated into emergency airway management, and limited evidence exists regarding its relationship with first-pass intubation success in emergency department patients.
This study is designed as a prospective observational study. Adult patients undergoing rapid sequence intubation after a clinical decision by the treating emergency physician will be consecutively enrolled. A disposable BIS sensor will be placed on the patient's forehead immediately before induction, and BIS monitoring will be performed continuously. The emergency physician performing the intubation will remain blinded to the BIS values throughout the procedure. A separate investigator, independent of clinical management, will record the BIS value at the time of laryngoscopy and intubation.
Importantly, BIS measurements will not be communicated to the treating physician and will not influence the timing of intubation, medication selection, medication dosing, or any other aspect of patient care. Therefore, this investigation is not intended to evaluate or validate the BIS device as a medical device intervention. Rather, BIS is used solely as a noninvasive measurement tool to objectively quantify anesthetic depth. The monitor consists of a disposable adhesive forehead sensor and poses minimal risk to participants.
The primary analysis will compare BIS values between patients with successful first-pass intubation and those requiring more than one intubation attempt. The study seeks to determine whether inadequate anesthetic depth is associated with failure of first-pass intubation. The findings may improve understanding of the role of anesthetic depth during emergency airway management and may contribute to strategies aimed at increasing first-pass success while reducing intubation-related complications.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Muhammed Türe, MD
- Telefonní číslo: +905054691764
- E-mail: erkangoksu@akdeniz.edu.tr
Studijní záloha kontaktů
- Jméno: Erkan Göksu, MD
- Telefonní číslo: 00905054691764
- E-mail: erkangoksu@akdeniz.edu.tr
Studijní místa
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Antalya, Turecko (Türkiye), 07059
- Nábor
- Akdeniz University Hospital
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Kontakt:
- Erkan Göksu, MD
- Telefonní číslo: 05054691764
- E-mail: erkangoksu@akdeniz.edu.tr
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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
- No traumatic injury to the frontal region that would interfere with placement of the Bispectral Index (BIS) sensor
Exclusion Criteria:
- Age younger than 18 years
- Pregnant patients
- Patients with cardiac arrest or hemodynamic instability at the time of enrollment
- Patients intubated without the rapid sequence intubation (RSI) protocol
- Refusal to participate in the study (by the patient or, where applicable, a legally authorized representative)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Adults Undergoing Rapid Sequence Intubation
Adult patients (≥18 years) undergoing rapid sequence intubation (RSI) in the emergency department following the treating physician's clinical decision.
A noninvasive Bispectral Index (BIS) sensor is placed on the patient's forehead before induction to continuously monitor anesthetic depth.
The treating physician remains blinded to the BIS values, which are recorded by an independent investigator and are not used to guide patient management or influence the intubation procedure.
Participants are analyzed according to first-pass intubation success.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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First-pass endotracheal intubation success
Časové okno: During the intubation procedure
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Intubation at first attempt
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During the intubation procedure
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Erkan Göksu, Akdeniz University School of Medicine Department of Emergency Medicine
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 identifikační čísla studie
- AUH (Aarhus University Hospital)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- MÍZA
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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