Plain English Summary
Background and study aims
Aspiration of gastric content is the entry of stomach contents into the lungs. It is a major complication during surgery with anaesthesia. Therefore before surgery it is important to know that the patient has fasted. It seems common knowledge that only a fasted patient can undergo elective surgery. Under normal circumstances a patient is considered fasted 6 hours after their last solid meal and 2 hours after the intake of clear fluids. A non-fasted patient has an increased anaesthetic risk. Trauma (injury) is believed to delay gastric (stomach) emptying and negatively affects fasting status. However, this assumption is not supported by broad evidence. It seems plausible that minor trauma (i.e. a forearm fracture) affects gastric emptying to a lesser degree than major trauma. The aim of this study is to find out whether a minor trauma (forearm fracture) can delay gastric emptying.
Who can participate?
Patients aged 18 and over with a forearm fracture that needs surgical repair
What does the study involve?
Gastric emptying is assessed by ultrasound scans of the upper left abdomen at admission and before surgery.
What are the possible benefits and risks of participating?
The possible benefit for the participants is a verified fasting status before surgery. This is beneficial for the anaesthetic management. The risks of an abdominal ultrasound scan are almost negligible.
Where is the study run from?
AUVA-Unfallkrankenhaus Wien Lorenz Böhler (Austria)
When is the study starting and how long is it expected to run for?
May 2017 to September 2018
Who is funding the study?
AUVA Institute for Traumatology Research (Austria)
Who is the main contact?
1. Dr Daniel Lahner
2. Prof. Gerhard Fritsch
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EK-29-2017
Study information
Scientific title
Does a forearm fracture delay gastric emptying assessed by ultrasound? A prospective observational study in adult trauma patients
Acronym
Study hypothesis
Null hypothesis: A forearm fracture does not delay gastric emptying.
Ethics approval
Ethics committee of AUVA hospitals, 05/07/2017, ref: EK-29-2017
Study design
Prospective observational single cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Preoperative gastric emptying
Intervention
The aim of this study is to test preoperative gastric emptying in patients with a fractured forearm. Gastric content will be assessed by an abdominal ultrasound examination at admission and before surgery. The total duration of the observation will be the time span between admission and eligibility for surgery (approx. 6-8 hours) with no additional follow up planned.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Gastric emptying, determined by measuring gastric content with an abdominal ultrasound examination at admission (baseline, timepoint 1) and at eligibility for surgery (timepoint 2)
Secondary outcome measures
1. Pain, measured using the visual analogue scale (VAS)
2. Medication/relevant co-morbidities, retrieved from medical history
3. Factors influencing the quality of the ultrasound examination, determined posthoc
Overall trial start date
01/05/2017
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients suffering from a forearm fracture that deems postponed urgent surgical fixation
2. Age 18+ years; no maximum age is specified in the protocol
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Pregnant patients
2. Patients with fractures that need urgent surgical intervention
3. Patients suffering from fractures in multiple locations
Recruitment start date
01/09/2017
Recruitment end date
31/12/2019
Locations
Countries of recruitment
Austria
Trial participating centre
AUVA Traumazentrum Wien
Donaueschingenstraße 13
Vienna
1200
Austria
Sponsor information
Organisation
AUVA Traumazentrum Wien
Sponsor details
Donaueschingenstraße 13
Vienna
1200
Austria
Sponsor type
Hospital/treatment centre
Website
Organisation
Ludwig Boltzmann Institute for Experimental and Clinical Traumatology
Sponsor details
Donaueschingenstraße 13
Vienna
1200
Austria
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
AUVA Institute for Traumatology Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. The study protocol is available upon request from Dr Daniel Lahner or from the local ethics committee (ethikkommission@auva.at) under the reference number EK-29-2017.
2. Dissemination of the study results by publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from the investigator (Dr Daniel Lahner). Available data: Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices). The data will be available beginning 3 months and ending 3 years following article publication to researchers who provide a methodologically sound proposal for data meta-analysis. Proposals should be directed to Dr Daniel Lahner. To gain access, data requestors will need to sign a data access agreement. Data will be made available via a secure encrypted file transfer service. Patient data is anonymised by consecutive numbering. The informed consent obtained from the participants includes approval of data sharing after deidentification.
Intention to publish date
01/09/2019
Participant level data
Available on request
Basic results (scientific)
Publication list