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Video Analysis of Prehospital Emergency Intubations

2019년 5월 6일 업데이트: University Hospital Inselspital, Berne

Evaluation of Prehospital Emergency Intubations Using Videolaryngoscopes

The Investigators' knowledge about pre-hospital emergency intubations is still limited. Various factors such as the average and the normal range of intubation time are still unknown. Since its launch Rega videotapes all intubation attempts with the C-MAC videolaryngoscope. The investigators prospectively analysed all routinely recorded intubation videos during one year performed by the Rega crews. The investigators analysed different parameters such as first pass success rate and the time to successfully intubate alongside with others. The goal was to find out more about this difficult procedure, about the problems which regularly occur and on what should be put particular emphasis during training.

연구 개요

상태

완전한

정황

상세 설명

Pre-hospital emergency intubations are especially hazardous. The incidence of unanticipated difficult airways is higher (9,3 % of prehospital intubations are more difficult than anticipated). The first attempt intubation success rates are lower and the rate of complications compared to in-hospital emergency intubations is higher.

There is conflicting evidence if first attempt intubation success rate in prehospital intubations differs between intubations performed by videolaryngoscopy and direct laryngoscopy. On the other hand in pre-hospital airway management, the use of a C-MAC videolaryngoscope improved the visualization of glottic structures significantly.

The C-MAC has recently launched a new version, which allows videotaping of intubations. Rega decided to videotape all intubation attempts for legal purposes and quality control. These videos are stored at a Rega-based secure central database.

The Investigators knowledge there is only one video-enhanced retrospective analyses of a limited number of videolaryngoscopic pre-hospital intubations.

So far, there is no video-enhanced prospective analysis of first attempt intubation success rates or of the time necessary for successful intubation with videolaryngoscopes in the pre-hospital setting available. Therefore, the investigators intend to determine the exact first attempt intubation success rate and the time necessary to successfully intubate, alongside with parameters such as the Cormack/Lehane grade, blade position (Macintosh vs Miller) and others (e.g. difficulties during intubation) in the pre-hospital physician-staffed HEMS-setting. The investigators' goal is to learn more about what is actually happening during prehospital intubations and what type of difficulties may occur.

The investigators therefore prospectively analysed all routinely recorded intubation videos (using the built-in camera of the C-MAC videolaryngoscope) during one year performed by the Rega crews. These videos show real life intubations through the video function included in the device, only the image from the tip of the laryngoscopy blade inside the patient's mouth is recorded. The operating physicians additionally provided anonymous information about intubation management for each video after returning to the helicopter base

연구 유형

관찰

등록 (실제)

422

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

스위스
- - Bern, 스위스, 3011
    - Bern University Hospital and University of Bern

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

All Patients which underwent Intubation performed by the Rega during 1year (15.02.18-14.02.19) because of medical or Trauma associated reasons (with or without cardiac arrest).

설명

Inclusion Criteria:

• All videos routinely taken from intubations performed during 1 year at the Swiss Air Rescue (Rega) at all 13 helicopter bases

Exclusion Criteria:

Patients who were intubated primarily using other devices without a camera
Intubations that were not recorded (missing data).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
First attempt intubation success rate 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	Rate of a successful intubation at first attempt	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured

2차 결과 측정

결과 측정	측정값 설명	기간
Overall success rate 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	The overall rate of successful intubation	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Time intervals during intubation 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	entry-to-tube time (C-MAC crossing the lips to first appearance of tracheal tube in the field of view), time to intubation (C-MAC crossing the lips for the first time until passage of the tube through the vocal cords, the video is kept running throughout the intubation procedure), time between passage of the tube until removal of the blade from the mouth, overall time (from C-MAC crossing the lips for the first time until removal, the video is kept running throughout the intubation procedure), tube time (time from first appearance of the tube in the field until passage of the tube through the vocal cords), intubation time of the successful intubation attempt (C-MAC crossing the lips in the successful attempt until passage of the tube through vocal cords)	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Number of intubation attempts 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	The total number of attempts needed for the intubation	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Best C/L(Cormack/ Lehane 1-4) grade and best POGO (percent of glottis Opening 0 - 100 %) score 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	The best C/L and best POGO score achieved during the intubation	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Additional Airway devices used 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	If additional devices have been used (e.g. Frova-like,catheter, Magill forceps, suction catheter)	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Number of glottic hits 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	Number of attempts to advance the tracheal tube, but only glottic structures are being hit	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Blade positioning 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	Blade positioning during intubation (Macintosh vs. Miller)	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Unintended blade positions 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	Unintended blade positions (too deep, downfolding of epiglottis)	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Secretion in the mouth and difficulties in visualisation because of it 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	Vomit, blood, saliva	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Fogging of the camera 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	videolaryngoscope camera clear or fog	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Oesophageal intubation 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	Oesophageal fail intubation during the procedure	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Injury of the pharyngeal mucose due to the blade 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	Videolaryngoscope injury of the pharyngeal mucose due to the blade	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Open or Closed vocal cords 기간: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured	Positioning of vocal cords if visible (open, closed), start of movement of vocal cords	Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital Inselspital, Berne

수사관

수석 연구원: Lorenz Theiler, Prof., Department of Anaesthesiology and Pain Therapy, Bern University Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 2월 15일

기본 완료 (실제)

2019년 2월 14일

연구 완료 (실제)

2019년 2월 14일

연구 등록 날짜

최초 제출

2019년 4월 17일

QC 기준을 충족하는 최초 제출

2019년 4월 24일

처음 게시됨 (실제)

2019년 4월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 5월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 5월 6일

마지막으로 확인됨

2019년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

2017-02104

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .