AnesthesiaNCT06643325
Gastric Emptying Time in Traumatic Injuries
An observational study of Anesthesia and Gastric Ultrasound, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) to estimate the gastric emptying time and dependant factors after traumatic injurys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Gastric Ultrasound, Sonography
- What is being tested?
- Gastric ultrasound
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to the emergency department with a relevant traumatic injury
Who may be able to join
- relevant traumatic injury
Who cannot join
- life-threatening traumatic injury (immediate treatment is necessary)
- Underage
- Known pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Winterthur
Winterthur, 8401
Roman Meierhans, resident, 052 266 48 46, Roman.Meierhans@ksw.ch
Sascha Bättig, resident
About this study
Official title: Gastric Point-of-care Sonography with Focus on Gastric Emptying Time in Patients with Traumatic Injuries. a Prospective Observational Study
The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) to estimate the gastric emptying time and dependant factors after traumatic injurys.
Read the detailed description
The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) in patients suffering from a relevant traumatic injury. Patients which are admitted to the emergency department with a corresponding history are considered for inclusion. Patient with life-threatening injuries are excluded. After inclusion, the investigators plan to carry out gastric ultrasound (POCUS) all 2 hours until the operative treatment (maximal 5 examinations). To identify factors which may be correlated with delayed gastric emptying several demographic and patient related factors are collected.
- Conditions
- Anesthesia, Gastric Ultrasound, Sonography, Point of Care Ultrasound (POCUS), Regurgitation, Pulmonary Aspiration During Anesthetic Induction
- Being tested
- Gastric ultrasound
- Keywords
- point of care ultrasound, gastric ultrasound, trauma patients, aspiration, anesthesia
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundDiagnostic test
Serial, gastric sonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic quality/quantity of the gastric antrum
Quality of the gastric content (empty, fluid, solid or mixed fluid/solid) and quantity of the gastric content in ml, measured in 2 hour time intervals
Measured: 2 hour
Secondary outcomes (3)
Pain-scale
Evaluate pain using the VAS Scale 0-10 (Visual Analog Scale)
Measured: 2 hour
Analgetics
Evaluate need of analgetics
Measured: 2 hour
Stress, activation of sympathic nerve system
Evaluate stress on a VAS 0-10 (Visual Analog Scale)
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Feb 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643325
- Sponsor's protocol ID
- POCUS 2
- Status last verified
- Oct 2024
- First submitted
- 3 Apr 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Point-of-care Sonography with Focus on Gastric Emptying Time in Patients with Traumatic Injuries. a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06643325
- Acronym / sponsor ID
- POCUS 2
- Conditions
- Anesthesia, Gastric Ultrasound, Sonography, Point of Care Ultrasound (POCUS), Regurgitation, Pulmonary Aspiration During Anesthetic Induction
- Keywords
- point of care ultrasound, gastric ultrasound, trauma patients, aspiration, anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) to estimate the gastric emptying time and dependant factors after traumatic injurys.
Detailed description
The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) in patients suffering from a relevant traumatic injury. Patients which are admitted to the emergency department with a corresponding history are considered for inclusion. Patient with life-threatening injuries are excluded. After inclusion, the investigators plan to carry out gastric ultrasound (POCUS) all 2 hours until the operative treatment (maximal 5 examinations). To identify factors which may be correlated with delayed gastric emptying several demographic and patient related factors are collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to the emergency department with a relevant traumatic injury
Key inclusion criteria (1 listed)
- relevant traumatic injury
Key exclusion criteria (3 listed)
- life-threatening traumatic injury (immediate treatment is necessary)
- Underage
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric ultrasoundSerial, gastric sonography | Diagnostic test | – |
Primary outcome
Sonographic quality/quantity of the gastric antrum
Time frame: 2 hour
Quality of the gastric content (empty, fluid, solid or mixed fluid/solid) and quantity of the gastric content in ml, measured in 2 hour time intervals
3 secondary outcomes
Pain-scale
Time frame: 2 hour
Analgetics
Time frame: 2 hour
Stress, activation of sympathic nerve system
Time frame: 2 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Gastric Ultrasound, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographic quality/quantity of the gastric antrum (time frame: 2 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.