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The incidence and clinical implications of "full stomach"in an elective surgical population. An observational study using bedside sonography.


- candidate number27355
- NTR NumberNTR6522
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jun-2017
- Secondary IDs2015-2010 
- Public TitleThe incidence and clinical implications of "full stomach"in an elective surgical population. An observational study using bedside sonography.
- Scientific TitleThe incidence and clinical implications of "full stomach"in an elective surgical population. An observational study using bedside sonography.
- ACRONYM
- hypothesisTo determine the proportion of patients that present for elective surgical procedures with a "full stomach"despite following standard Fasting instructions
- Healt Condition(s) or Problem(s) studiedEchocardiography, Aspiration, Full stomach
- Inclusion criteria18 years of age or older, scheduled for elective surgery under either regional or general anaesthesia.
- Exclusion criteriapre-existing structural abnormality of the upper gastro-intestinal tract, pregnancy and emergency surgery
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 15-jun-2017
- planned closingdate1-dec-2019
- Target number of participants0
- InterventionsPre-operative a focused ultrasound examination of the stomach in supine and right lateral decubitus position.
- Primary outcomeIncidence of "full stomach"despite follwoing standard Fasting instructions for elective surgical procedures
- Secondary outcomeAspiration
Probable intra-operative aspiration
aspiration pneumonitis/pneumonie
ARDS, pneumonie, ALI, death
- TimepointsPrimary outcome is pre-operative
Secondary outcome is intra-operative AND first 7 days post-operative
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMCT Tacken
- CONTACT for SCIENTIFIC QUERIESMCT Tacken
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center St. Radboud
- Publications
- Brief summaryThe incidence and clinical implications of “full stomach” in an elective surgical population. An observational study using bedside sonography
Summary
Introduction
Pulmonary aspiration of gastric content is a serious perioperative complication associated with significant morbidity and mortality.
Bedside Gastric ultrasonography (GUS) is a non-invasive tool that provides both qualitative and quantitative information about gastric contents.
The primary aim of this observational study is to determine the proportion of patients that present for elective surgical procedures with a “full stomach” despite following standard fasting instructions
A secondary objective is to evaluate common respiratory outcomes in this subset of patients who undergo elective surgery with a “full stomach”.

Methods
All patients 18 years of age or older, scheduled for elective surgery under either regional or general anesthesia will be included. Exclusion criteria will be: pre-existing structural abnormality of the upper gastro-intestinal tract (e.g. previous lower esophageal or gastric surgery, hiatal hernia, gastric cancer), pregnancy and emergency surgery. An observational study during a two-year period.
On the surgical date a complete medical history and demographic data will be registered. A focused ultrasound examination of the stomach will be performed. The nature of the content (none, clear fluid or thick fluid/solid) will be documented based on qualitative sonographic features. For clear fluids, a previously described 3-point grading system will be used.
No further evaluations will be performed in subjects with an “empty stomach”. Conversely, a more detailed gastric ultrasound examination will be performed on all patients with a “full stomach” and they will be followed prospectively for 7 days to document respiratory outcomes.

Data management
All data will be gathered prospectively and documented in writing. Data will summarized using descriptive statistics. Count and percentages will be used for categorical variables, and mean and standard deviation for continuous variables
- Main changes (audit trail)
- RECORD6-jun-2017 - 23-jul-2017


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