- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04866446
Evaluation of The Effects of Personal Protective Equipment During Airway Management
Evaluation of The Effects of Personal Protective Equipment During Airway Management; A Prospective, Non-randomized, Controlled, Simulation Study
연구 개요
상세 설명
Objective: The investigators aimed to compare the effects of the use of personal protective equipment and standard uniform during airway management using direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope, I-gel laryngeal mask airway , ProSeal laryngeal mask airway and Frova intubation catheter on the manikin that created both difficult airway and normal airway conditions in the Department of Anesthesiology and Reanimation at the Derince Training and Research Hospital, University of Health Sciences.
Materials and Methods: The study will carry out with 24 participants in Health Sciences University Kocaeli Derince Health Education and Research Center. In the study, a simulation manikin will use to evaluate the effect of personal protective equipment use on airway management. Anesthesia technicians, anesthesia residents and specialists will include as participants. As demographic data, the clinical positions of the participants, their experiences with each airway method and the use of personal protective equipment, age, gender, height and weight information will be recorded. Each procedure will be explained to the participants by an anesthesiology specialist and a resident. Then the participants perform their procedure first with standard uniform and then by wearing personal protective equipment. Endotracheal intubation with direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter followed by I-gel and ProSeal laryngeal mask airway will be used, respectively. Each procedure will be carried out by creating normal and difficult airway conditions, respectively. Time, number of attempts and presence of optimization maneuver will be recorded for each procedure. Modified CLS (Cormack Lehane Score) and POGO (Percentage Of Glottic Opening) scores will be also recorded during intubation procedures. Each participant will be asked to give a score between 1 and 100 using the Visual Analogue Scale (VAS) in order to evaluate the difficulty of intervention after each procedure subjectively and it will be recorded. Finally, the other subjective effects of personal protective equipment using on participants (such as sweating, feeling of warmth) will be asked.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Kocaeli̇
-
Kocaeli, Kocaeli̇, 칠면조, 41900
- Aydan Okuyucu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Being an anesthesiology resident, specialist or nurse
Exclusion Criteria:
- Anxiety Disorder
- Severe heart or lung disease
- Claustrophobia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
normal airway manikin with standard uniform
The participants will carry out intubation procedure using macintosh direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter and laryngeal mask insertion using ProSeal LMA and I-gel LMA, respectively.
|
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
|
|
normal airway manikin with personal protective equipment
The participants will carry out intubation procedure using macintosh direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter and laryngeal mask insertion using ProSeal LMA and I-gel LMA, respectively.
|
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
|
|
difficult airway manikin with standard uniform
The participants will carry out intubation procedure using macintosh direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter and laryngeal mask insertion using ProSeal LMA and I-gel LMA, respectively.
|
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
|
|
difficult airway manikin with personal protective equipment
The participants will carry out intubation procedure using macintosh direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter and laryngeal mask insertion using ProSeal LMA and I-gel LMA, respectively.
|
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluation of times
기간: 2 minutes
|
For intubations from holding the laryngoscope to ventilation, for laryngeal mask airway insertion from holding the laryngeal mask airway to ventilation For intubation time from holding the laryngoscope to observing glottic opening for standard uniform.
|
2 minutes
|
|
Evaluation of times
기간: 4 minutes
|
For intubations from holding the laryngoscope to ventilation, for laryngeal mask airway insertion from holding the laryngeal mask airway to ventilation For intubation time from holding the laryngoscope to observing the glottic opening for personal protective equipment.
|
4 minutes
|
|
Evaluation of number of attempts
기간: 2 minutes
|
For both intubation and laryngeal mask airway insertion, number of attempts until ventilation
|
2 minutes
|
|
Evaluation of presence of optimisation maneuver
기간: 30 seconds
|
Whether there is optimisation maneuver for each attempt whether there is maneuver for each attempt
|
30 seconds
|
|
Evaluation of Modified Cormack/Lehane classification
기간: 30 seconds
|
The classification includes 5 grades; grade 1, 2a, 2b, 3 and 4. Grade 1 defines the best image of glottis.
|
30 seconds
|
|
Evaluation of Percentage of Glottic Opening Scores
기간: 30 seconds
|
Percentage of Glottic Opening describes the percentage of the glottic opening as percentages (0-100).
Number 100 describes that the participants see all glottic openings.
Number 0 describes that nothing is seen.
|
30 seconds
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Visual Analog Scale of using personal protective equipment
기간: 15 minutes
|
The visual analog scale is a scale that converts a subjective property to digital data.
It has values between 0-100.
Generally it is used for describing pain level.
But it is used for describing the difficulty of attempts in this study.
Number 0 explains that the attempt is very easy and number 100 is very difficult.
|
15 minutes
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Mehmet Yilmaz, 2, University of Healt Sciences, Kocaeli Derince Education and Research Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- derinceanesteziaydan-1
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. .
기도 관리에 대한 임상 시험
-
Sohag University아직 모집하지 않음Supra Glottic Airway 장치를 사용한 측두하악 관절 기능의 변화