Influence of forearm fractures on gastric emptying
| ISRCTN | ISRCTN45206639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45206639 |
| Secondary identifying numbers | EK-29-2017 |
- Submission date
- 21/08/2017
- Registration date
- 12/09/2017
- Last edited
- 03/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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 October 2023
Who is funding the study?
AUVA Institute for Traumatology Research (Austria)
Who is the main contact?
1. Dr Daniel Lahner
2. Prof. Gerhard Fritsch
Contact information
Scientific
Donaueschingenstraße 13
Vienna
1200
Austria
Scientific
Donaueschingenstraße 13
Vienna
1200
Austria
Study information
| Study design | Prospective observational single cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Does a forearm fracture delay gastric emptying assessed by ultrasound? A prospective observational study in adult trauma patients |
| Study objectives | Null hypothesis: A forearm fracture does not delay gastric emptying. |
| Ethics approval(s) | Ethics committee of AUVA hospitals, 05/07/2017, ref: EK-29-2017 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2017 |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key exclusion criteria | 1. Pregnant patients 2. Patients with fractures that need urgent surgical intervention 3. Patients suffering from fractures in multiple locations |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 01/09/2023 |
Locations
Countries of recruitment
- Austria
Study participating centres
Vienna
1200
Austria
Salzburg
5010
Austria
Sponsor information
Hospital/treatment centre
Donaueschingenstraße 13
Vienna
1200
Austria
| Website | www.ukhlorenzboehler.at/ |
|---|
Research organisation
Donaueschingenstraße 13
Vienna
1200
Austria
| Website | http://trauma.lbg.ac.at/ |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Editorial Notes
03/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/09/2021 to 01/09/2023.
2. The overall trial end date has been changed from 31/10/2021 to 31/10/2023.
3. The intention to publish date has been changed from 31/12/2021 to 31/12/2023.
15/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 01/09/2021.
2. The overall trial end date has been changed from 31/12/2018 to 31/10/2021.
3. The intention to publish date has been changed from 01/09/2019 to 31/12/2021.
4. The trial participating centre AUVA Trauma Centre Salzburg was added.
06/12/2018: The recruitment end date has been updated from 01/10/2018 to 31/12/2019.
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).
