- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Erkan Göksu, MD
- 전화번호: +905054691764
- 이메일: erkangoksu@akdeniz.edu.tr
연구 장소
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Antalya, 터키 (Türkiye), 07059
- 모병
- Akdeniz University Hospital
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연락하다:
- Erkan Göksu, MD
- 전화번호: 05054691764
- 이메일: erkangoksu@akdeniz.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Diastolic Blood Pressure Following Rapid Sequence Intubation
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AkdenizUH1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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