Full Stomach Clinical Trial
— GAASOfficial title:
Gastric Assessment in Ambulatory Surgery : a Prospective Study
Verified date | March 2020 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | February 20, 2020 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Uhmontpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The prevalence of patients with a "full stomach" based on ultrasound criteria. | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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