Gastric Assessment Ambulatory Surgery (GAAS)
Gastric Assessment in Ambulatory Surgery : a Prospective Study
The surgical procedures in outpatient surgery are in perpetual increase. However, the peri operative stress can reduce the gastric emptying. A patient's compliance for following the fasting rules cannot be controlled at home. Ambulatory surgery is currently proposed to fragile patients with many comorbidities known to slow gastric emptying. In day case surgery the airway management are often managed with supraglottic device ( laryngeal mask). This device does not protect the respiratory tract and may expose the patient to a risk of inhalation of gastric content (if not empty).
This study aim to mesure the prevalence of full stomachs in outpatient surgery and to observe any changes in anesthetic management secondary to the ultrasound assessment of gastric content. It will confront theoretical full stomach risk factors with ultrasound findings. The practical and clinical relevance of such a technique in the context of outpatient surgery will be assessed in this study. The ultimate goal is to improve the safety of the patient's anesthetic management by controlling the risk of pulmonary aspiration.
연구 개요
상세 설명
Patients will be included during the pre-anesthetic evaluation. The theoretical full stomach risk factors and the anesthetic management will be recorded in the computerized pre-anesthetic evaluation.
A qualitative and quantitative ultrasound evaluation will be performed when the patient arrives in the pre-anesthesia room. The examination will be performed in the right lateral decubitus with a low frequency convex ultrasound probe.
The main objective is to measure the prevalence of patients with a "full stomach" based on ultrasound criteria.
The primary endpoint is the presence of solid or fluid greater than 1.5 ml / kg of the predicted ideal body weight during ultrasonographic evaluation of gastric contents. In this situation, the patient will be considered at high risk of inhalation (considered full stomach).
This study will observe and record any anesthetic changes (ie : airway management) secondary to this ultrasouund assessment of gastric contents.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Montpellier, 프랑스, 34295
- Uhmontpellier
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Affiliation to social security. Be over 18 years old. Have signed informed consent for this study. Score from the American Society of Anesthesiology (ASA) 1, 2, or 3. Being admitted for ambulatory day care surgery.
Exclusion criteria:
Patients who are protected or unable to give consent Patients with cognitive dysfunction, or unable to give their consent according Pregnant or lactating women. Vulnerable people. Patients with a history of esophageal or gastric surgery Patients suffering from hiatal hernia with esophageal reflux
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The prevalence of patients with a "full stomach" based on ultrasound criteria.
기간: one hour
|
The presence of solid or fluid greater than 1.5 ml / kg of the predicted ideal body weight during ultrasonographic evaluation of gastric contents.
|
one hour
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Philippe BIBOULET, MD, University Hospital, Montpellier
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
- RECHMPL17_0289
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .