- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01790646
Learning and Performance of Glidescope® Videolaryngoscope Intubation
Learning and Performance of Glidescope® Videolaryngoscope Intubation in Anesthesiologists Trained in Direct Laryngoscopy: a "in Vivo" Study
연구 개요
상세 설명
Glidescope® Videolaryngoscope is an angulated rigid optical device introduced in clinical practice in 2004 to facilitate endotracheal intubation.
Since its introduction potential benefits of this instrument might lie with use in patients with clinical features indicating difficult laryngoscopy or it being used as a rescue method following failed direct laryngoscopy. In a few centers was proposed and used routinely.
The performance of Glidescope® was studied in easy and difficult scenarios, in vivo and on manikins and compared with the reference standard McIntosh direct laryngoscopy. In patients with predicted or simulated difficult intubation, despite glottis visualization was improved with Glidescope®, the introduction of the tube in trachea was difficult the same as with McIntosh laryngoscopy. Training of operators before to entertain the trials varied from 20 to 50 Glidescope successful intubations. In an observational study Aziz et al. demonstrated in the two Institutions involved that the GlideScope® was used more frequently at the Institution were the failure rate was significantly lower. At this , 51 providers performed mean 21.7 GlideScope® intubations while at the other 91 providers performed 9.9 intubations.
These data highlight the important issue of how many Glidescope® intubations a provider should complete to reach a definitive clinical competence in this practice. Until now there is only one study performed on mankin comparing Glidescope® with AirTraq® and McIntosh laryngoscopes in novices . The authors concluded that despite a steep learning curve after 5 intubation difficulties in instrumentation and longer times to intubate persisted with Glidescope® in comparison with the other two devices. Outcome measures were: duration of intubation attempt, modified Cormack grades, dental trauma and difficulty of use.
In vivo both timely insertion of laryngoscope blade and introduction of the tube, no need of help or of external laryngeal displacement should be included to ascertain expertise with this new technology in patients with different grades of difficulty predicted.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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-
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Milan, 이탈리아, 20136
- 모병
- Istituto Neurologico Besta
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연락하다:
- Paolo Cortellazzi, MD
- 전화번호: 2420 +39022304
- 이메일: paolo.cortellazzi@istituto-besta.it
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부수사관:
- Alberto Sommariva, MD
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Milano, 이탈리아, 20136
- 모병
- Istituto Neurologico Besta
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연락하다:
- Massimo Lamperti, MD
- 전화번호: 2420 +39022394
- 이메일: paolo.cortellazzi@istituto-besta.it
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수석 연구원:
- Paolo Cortellazzi, MD
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- any patient undergoing GA
Exclusion Criteria:
- patients with predicted difficult intubation undergoing awake intubation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
patients undergoing general anesthesia
every elective patient undergoing general anesthesia for neurosurgical procedures with endotracheal intubation
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intubation using Glidescope videolaryngoscope
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient
기간: from induction of GA to successful intubation
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from Glidescope blade insertion to succefull introduction of the tracheal tube and tube secured in the trachea with ETCO2 confirmation of tracheal ventilation
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from induction of GA to successful intubation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Features useful to define a Glidescope intubation successful
기간: successfull intubation
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the following criteria have to be satisfied: one introduction of the laryngoscope, one introduction of the tube, Cormack-leane 1, no external laryngeal displacement, time to intubation <43 seconds, no need for help of an external operator, no complications
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successfull intubation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Paolo Cortellazzi, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- INCCB 2012-02
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. .
마취 삽관 합병증에 대한 임상 시험
-
Second Military Medical University완전한Transillumination-guided Fiberoptic Intubation 삽관법중국