- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04317976
Ultrasound Guided Cricoid and Paralaryngeal Pressure
Impact of Ultrasound Guidance on the Performance of Accurate Cricoid and Paralaryngeal Pressure
연구 개요
상세 설명
All patients consented for the study were having their airway examined via US. Cross sectional sonography of the airway was performed to determine the anatomic relationship of the oesophagus relative to the trachea:
- before induction of anaesthesia
- after GA before external airway pressure manoeuvre
- after GA with external airway pressure manoeuvre.
US guided CP was applied on subjects with central oesophagus; CP and PLP were applied on subject with eccentric oesophagus anatomy.
PLP was performed by lateral compression on the eccentric oesophagus by fingertips under US guidance. To standardised the application of CP and PLP, only 2 well trained investigators were allowed to performed the CP and PLP, US scan on airway and patient recruitment. The conduct of trial involved 2 investigators where first investigator provide US scan, and second investigator provide compression of CP or PLP using fingertips guided by the instruction of first investigator.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Elective list Under general anaesthesia Not intubated prior to OT
Exclusion Criteria:
Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Centrally located oesophagus post GA
Oesophagus remained central after general anaesthesia, cricoid pressure applied by fingertips under ultrasound guidance
|
cricoid pressure by fingertips applied under ultrasound guidance
|
|
실험적: Eccentric located oesophagus post GA
Oesophagus eccentric located after general anaesthesia, paralaryngeal pressure and cricoid pressure applied by fingertips under ultrasound guidance
|
cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The number of patients with eccentric oesophagus under general anesthesia, successfully occluded by using cricoid and paralaryngeal pressure.
기간: ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure
|
we are studying the effectiveness of cricoid pressure versus cricoid and paralaryngeal pressure(novel technique) in those patients with eccentric oesophagus under general anaesthesia.
We use ultrasound to determined the position of the oesophagus after patient under general anaethesia ( to group them under central oesophagus and eccentric oesophagus) and also to determine the success of oesophagus occlusion.
|
ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The number of patients with central oesophagus under general anesthesia, successfully occluded by using cricoid pressure.
기간: ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure
|
The objective is to study the effectiveness of cricoid pressure in those patients with central oesophagus under general anaesthesia.
We use ultrasound to determined the position of the oesophagus after patient under general anaethesia, and also to determine the success of oesophagus occlusion.
|
ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
incidence of variation of oesophagus position before and after general anaesthesia
기간: ultrasound assessment of position of oesophagus before and after general anaesthesia
|
We use ultrasound to determine the position of osephagus (central or eccentric) to determine the incidence of variation of oesophagus position before and after general anaesthesia.
|
ultrasound assessment of position of oesophagus before and after general anaesthesia
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Siu Min Lim, M. Anaes, University of Malaya
간행물 및 유용한 링크
일반 간행물
- SELLICK BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961 Aug 19;2(7199):404-6. doi: 10.1016/s0140-6736(61)92485-0. No abstract available.
- Andruszkiewicz P, Wojtczak J, Wroblewski L, Kaczor M, Sobczyk D, Kowalik I. Ultrasound evaluation of the impact of cricoid pressure versus novel 'paralaryngeal pressure' on anteroposterior oesophageal diameter. Anaesthesia. 2016 Sep;71(9):1024-9. doi: 10.1111/anae.13518.
- Lee D, Czech AJ, Elriedy M, Nair A, El-Boghdadly K, Ahmad I. A multicentre prospective cohort study of the accuracy of conventional landmark technique for cricoid localisation using ultrasound scanning. Anaesthesia. 2018 Oct;73(10):1229-1234. doi: 10.1111/anae.14399. Epub 2018 Jul 25.
- Rice MJ, Mancuso AA, Gibbs C, Morey TE, Gravenstein N, Deitte LA. Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. Anesth Analg. 2009 Nov;109(5):1546-52. doi: 10.1213/ane.0b013e3181b05404.
- Byas-Smith M, Prinsell JR Jr. Ultrasound-guided esophageal occlusion during rapid sequence induction. Can J Anaesth. 2013 Mar;60(3):327-8. doi: 10.1007/s12630-012-9847-9. Epub 2012 Dec 20. No abstract available.
- Votruba J, Zemanova P, Lambert L, Vesela MM. The Role of Airway and Endobronchial Ultrasound in Perioperative Medicine. Biomed Res Int. 2015;2015:754626. doi: 10.1155/2015/754626. Epub 2015 Dec 14.
- Bhatia N, Bhagat H, Sen I. Cricoid pressure: Where do we stand? J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):3-6. doi: 10.4103/0970-9185.125683.
- Kei J, Utschig EE, van Tonder RJ. Using Ultrasonography to Assess the Effectiveness of Cricoid Pressure on Esophageal Compression. J Emerg Med. 2017 Aug;53(2):236-240. doi: 10.1016/j.jemermed.2017.04.025. Epub 2017 Jun 8.
- Smith KJ, Dobranowski J, Yip G, Dauphin A, Choi PT. Cricoid pressure displaces the esophagus: an observational study using magnetic resonance imaging. Anesthesiology. 2003 Jul;99(1):60-4. doi: 10.1097/00000542-200307000-00013.
- Smith KJ, Ladak S, Choi PT, Dobranowski J. The cricoid cartilage and the esophagus are not aligned in close to half of adult patients. Can J Anaesth. 2002 May;49(5):503-7. doi: 10.1007/BF03017931.
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
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