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Bispectral Index and First-Pass Intubation

2 lipca 2026 zaktualizowane przez: Erkan Göksu, Akdeniz University Hospital

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.

Przegląd badań

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

150

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Adult patients ındergoing RSı in the ED

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
First-pass endotracheal intubation success
Ramy czasowe: During the intubation procedure
Intubation at first attempt
During the intubation procedure

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Dyrektor Studium: Erkan Göksu, Akdeniz University School of Medicine Department of Emergency Medicine

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2028

Ukończenie studiów (Szacowany)

1 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

2 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lipca 2026

Pierwszy wysłany (Rzeczywisty)

8 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • AUH (Aarhus University Hospital)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

De-identified individual participant data collected during the study may be shared with qualified researchers upon reasonable request and after approval by the study investigators. Shared data may include demographic characteristics, clinical variables, intubation-related parameters, Bispectral Index values, and outcome data related to first-pass endotracheal intubation success. All shared data will be anonymized to protect participant confidentiality.

Ramy czasowe udostępniania IPD

De-identified individual participant data and supporting documents will be available after publication of the primary results. The data will be available for a period of 5 years following publication.

Kryteria dostępu do udostępniania IPD

De-identified individual participant data may be shared with qualified researchers upon reasonable request and approval by the study investigators. Researchers will be provided access to data necessary for the approved research purpose, including demographic characteristics, clinical variables, Bispectral Index measurements, intubation-related variables, and primary outcome data. Access will be provided after ensuring appropriate data protection and confidentiality measures.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • SOK ROŚLINNY
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

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