The purpose of this study is to examine in healthy volunteers or the research results can be reproduced for the measurement of the stomach contents in our center. It is not the aim to validate the formula of Perlas et al.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Maaginhoud
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the area of the stomach in cm2
Secondary outcome
nvt
Background summary
The introduction in giving general anesthesia is one of the moments with the
greatest risk of complications. One of the possible complications is the
aspiration of gastric contents. Setting a period of fasting before undergoing
general anesthesia has reduced this risk. This is not possible for acute for
emergency interventions. In addition, having pain and analgesia can have a
negative effect on emptying of the stomach. Would it be possible to use the
echo to produce a reliable measure for estimating the stomach contents?
Perlas et al. carried out several studies for the measurement of the gastric
content for elective surgery. It has been shown that the measurement of the
antrum of the stomach corresponds the best to the actual stomach contents.
Study objective
The purpose of this study is to examine in healthy volunteers or the research
results can be reproduced for the measurement of the stomach contents in our
center. It is not the aim to validate the formula of Perlas et al.
Study design
The research design of this pilot study is a prospective observational study.
The study population consists of healthy volunteers of at least 18 years old.
The primary outcome measure is the surface area of the antrum of the stomach,
which could be compared with the amount of food ingested. The surface area is
determined with the aid of an echo.
Study burden and risks
The burden for the subjects consists only of time and to be sober before
undergoing ultrasound examination. Volunteers must drink 2x 250 ml of water and
ingest a solid meal.
Dokter van Heesweg 2 Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2 Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- ASA (anesthesiologists physical status classification) classification I or II
- Volunteers must be able to understand the study protocol and to give informed consent
Exclusion criteria
- Volunteers who are at risk of a enlarged stomach or delayed gastric emptying, (pregnancy, diabetes, history of reflux disease, other disorders of the stomach / esophagus, history of surgery on the upper part of the digestive tract).
- Volunteers who are not able to understand the study protocol and to give informed consent
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 |
|---|---|
| CCMO | NL57413.075.16 |