No registrations found.
ID
Source
Health condition
aspiration, ultrasound, gastric, full stomach
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of "full stomach"despite follwoing standard Fasting instructions for elective surgical procedures
Secondary outcome
Aspiration
Probable intra-operative aspiration
aspiration pneumonitis/pneumonie
ARDS, pneumonie, ALI, death
Background summary
The 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
Study objective
To determine the proportion of patients that present for elective surgical procedures with a "full stomach"despite following standard Fasting instructions
Study design
Primary outcome is pre-operative
Secondary outcome is intra-operative AND first 7 days post-operative
Intervention
Pre-operative a focused ultrasound examination of the stomach in supine and right lateral decubitus position.
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6330 |
NTR-old | NTR6522 |
Other | : 2015-2010 |