Hip FracturesNCT03242733
Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip Fracture
An observational study of Hip Fractures, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric contents will be examined by using ultrasonography in fasted elderly patients scheduled for hip fracture surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Ultrasound assessment of gastric contents
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Dec 2017to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Who has hip fracture and agrees with the purpose of the study
Who may be able to join
- Who has hip fracture and agrees with the purpose of the study
Who cannot join
- gastrointestinal pathology
- history of any type of gastrectomy
- gastrointestinal anomaly
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
Jin-Young Hwang, M.D., +82-2-870-2518, mistyblue15@naver.com
About this study
Official title: Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip
Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric contents will be examined by using ultrasonography in fasted elderly patients scheduled for hip fracture surgery. The primary outcome is the number of patients with stomach contents, and the secondary outcome is the component of residual gastric contents.
Read the detailed description
In the patients who has femur fracture, they are immobilized because of the pain. This condition makes the gastric movement slow, and the pain also contributes to delayed digestion.
In the present study, the gastric content is assessed by using ultrasonography in fasted elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine position. All patients scheduled elective surgery for hip fracture over 65 years old are objects. The primary outcome is the number of patients with not empty stomach and full stomach, and the secondary outcome is the component of residual gastric contents.
- Conditions
- Hip Fractures
- Being tested
- Ultrasound assessment of gastric contents
- Keywords
- Gastroparesis
- Medical subject headings
- Hip Fractures, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessment of gastric contentsOther
Ultrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery.
| Study group | Role | What they receive |
|---|---|---|
| Hip fracture patients | Fasted elderly patients scheduled for hip fracture surgery except exclusion criteria are enrolled. Receives: Other: Ultrasound assessment of gastric contents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound assessment of the presence of gastric contents.
The presence of of gastric contents is assessed by using ultrasonography; yes/no
Measured: Before the induction of anesthesia (Baseline)
Secondary outcomes (1)
Ultrasound assessment of the component of residual gastric contents
The component of residual gastric contents is assessed by using ultrasonography; empty, clear fluid, solid content
Measured: Before the induction of anesthesia (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start26 Dec 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Young Hwang, MD,phD, Study chair, Seoul National University Boramae Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242733
- Sponsor's protocol ID
- 20170804/10/2017/8
- Status last verified
- Apr 2018
- First submitted
- 4 Aug 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
PubMed 8424572Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
PubMed 17122571Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.
PubMed 19304443
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip
- ClinicalTrials.gov ID
- NCT03242733
- Acronym / sponsor ID
- 20170804/10/2017/8
- Conditions
- Hip Fractures
- Keywords
- Gastroparesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 8 Aug 2017 (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.
Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric contents will be examined by using ultrasonography in fasted elderly patients scheduled for hip fracture surgery. The primary outcome is the number of patients with stomach contents, and the secondary outcome is the component of residual gastric contents.
Detailed description
In the patients who has femur fracture, they are immobilized because of the pain. This condition makes the gastric movement slow, and the pain also contributes to delayed digestion.
In the present study, the gastric content is assessed by using ultrasonography in fasted elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine position. All patients scheduled elective surgery for hip fracture over 65 years old are objects. The primary outcome is the number of patients with not empty stomach and full stomach, and the secondary outcome is the component of residual gastric contents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip fracture patients | – | Other: Ultrasound assessment of gastric contentsFasted elderly patients scheduled for hip fracture surgery except exclusion criteria are enrolled. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Who has hip fracture and agrees with the purpose of the study
Key inclusion criteria (1 listed)
- Who has hip fracture and agrees with the purpose of the study
Key exclusion criteria (3 listed)
- gastrointestinal pathology
- history of any type of gastrectomy
- gastrointestinal anomaly
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 |
|---|---|---|
| Ultrasound assessment of gastric contentsUltrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery. | Other | Hip fracture patients |
Primary outcome
Ultrasound assessment of the presence of gastric contents.
Time frame: Before the induction of anesthesia (Baseline)
The presence of of gastric contents is assessed by using ultrasonography; yes/no
1 secondary outcome
Ultrasound assessment of the component of residual gastric contents
Time frame: Before the induction of anesthesia (Baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Background: PubMed 8424572Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
- Background: PubMed 17122571Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
- Background: PubMed 19304443Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jin-Young Hwang, MD,phD study chair
Seoul National University Boramae Hospital
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 Hip Fractures, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 24 Apr 2018. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Young Hwang, MD, phD (82-10-9553-0916, mistyblue15@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound assessment of the presence of gastric contents. (time frame: Before the induction of anesthesia (Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03242733, which also lists 3 linked publications.
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 24 Apr 2018.