Clinical Trials Directory

Trials / Completed

CompletedNCT03352401

Gastric Assessment Ambulatory Surgery

Gastric Assessment in Ambulatory Surgery : a Prospective Study

Status
Completed
Phase
Study type
Observational
Enrollment
500 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERUltrasouund assessment of gastric contentsA qualitative and quantitative ultrasound evaluationof the stomach will be performed when the patient arrives in the pre-anesthesia room. The examination will be held in the right lateral decubitus with a low frequency convex ultrasound probe.

Timeline

Start date
2017-11-27
Primary completion
2019-11-30
Completion
2020-02-20
First posted
2017-11-24
Last updated
2020-03-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03352401. Inclusion in this directory is not an endorsement.