Condition category
Surgery
Date applied
21/08/2017
Date assigned
12/09/2017
Last edited
01/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Daniel Lahner

ORCID ID

Contact details

Donaueschingenstraße 13
Vienna
1200
Austria

Type

Scientific

Additional contact

Prof Gerhard Fritsch

ORCID ID

Contact details

Donaueschingenstraße 13
Vienna
1200
Austria

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 measures

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

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

01/10/2018

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

www.ukhlorenzboehler.at/

Organisation

Ludwig Boltzmann Institute for Experimental and Clinical Traumatology

Sponsor details

Donaueschingenstraße 13
Vienna
1200
Austria

Sponsor type

Research organisation

Website

http://trauma.lbg.ac.at/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/12/2017: The following changes were made: 1. Recruitment end date was added. 2. Overall trial end date was changed from 01/09/2018 to 31/12/2018. 3. Renaming of trial participating centre (also sponsor).