|- candidate number||27355|
|- NTR Number||NTR6522|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jun-2017|
|- Secondary IDs||2015-2010 |
|- Public Title||The incidence and clinical implications of "full stomach"in an elective surgical population. An observational study using bedside sonography.|
|- Scientific Title||The incidence and clinical implications of "full stomach"in an elective surgical population. An observational study using bedside sonography.|
|- hypothesis||To 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) studied||Echocardiography, Aspiration, Full stomach|
|- Inclusion criteria||18 years of age or older, scheduled for elective surgery under either regional or general anaesthesia.|
|- Exclusion criteria||pre-existing structural abnormality of the upper gastro-intestinal tract, pregnancy and emergency surgery|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||15-jun-2017|
|- planned closingdate||1-dec-2019|
|- Target number of participants||0|
|- Interventions||Pre-operative a focused ultrasound examination of the stomach in supine and right lateral decubitus position. |
|- Primary outcome||Incidence of "full stomach"despite follwoing standard Fasting instructions for elective surgical procedures|
|- Secondary outcome||Aspiration |
Probable intra-operative aspiration
ARDS, pneumonie, ALI, death
|- Timepoints||Primary outcome is pre-operative|
Secondary outcome is intra-operative AND first 7 days post-operative
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MCT Tacken|
|- CONTACT for SCIENTIFIC QUERIES||MCT Tacken|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|University Medical Center St. Radboud|
|- Brief summary||The incidence and clinical implications of “full stomach” in an elective surgical population. An observational study using bedside sonography|
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”.
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.
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)|
|- RECORD||6-jun-2017 - 23-jul-2017|