UltrasoundNCT03276364
The Impact of Point-of-Care Ultrasound
An observational study of Ultrasound and Shock, run by Montefiore Medical Center.
Trial summary
Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound, Shock
- What is being tested?
- Ultrasound
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2014to 17 Apr 2015
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: * Could undergo both a POCUS and bioreactance assessment within 6 hours of admission from the emergency department or transfer from a medical floor. * Shock was defined as either systolic blood pressure less than 90 mmHg or 40 mmHg below baseline, necessity for vasopressors to maintain mean arterial pressure greater than 65 mmHg, or any evidence of acute organ hypoperfusion that was evident at the time of study enrollment as judged by the treating physician. * The patient needed to be in shock at the time of POCUS and bioreactance testing at time of enrollment in order to be included.
Who may be able to join
- Adults age 18 or older admitted to the MICU with a diagnosis of shock while a fellow was on duty.
Who cannot join
- None
About this study
Official title: The Impact of Point-of-Care Ultrasound Performed by Trainees to Improve the Prediction of Fluid Responsiveness in Patients With Shock
Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness.
In this prospective, observational study, pulmonary and critical care fellows are asked to make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre- and post-ultrasound assessments are compared using a bioreactance monitor and passive leg raise test as the gold standard of fluid responsiveness in this study.
- Conditions
- Ultrasound, Shock
- Being tested
- Ultrasound
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Point-of-care ultrasound examination by pulmonary and critical care fellow
| Study group | Role | What they receive |
|---|---|---|
| Shock | Not described Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
Increase of stroke volume index greater than 10% following passive leg raise testing
Measured: Immediately subsequent to performance of a point-of-care ultrasound exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start21 Jul 2014
- Primary completion17 Apr 2015
- Study completion17 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Medical Center
- Responsible party
- Principal investigator, Daniel G. Fein, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276364
- Sponsor's protocol ID
- 206-13
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 8 Sep 2017
- 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 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Point-of-Care Ultrasound Performed by Trainees to Improve the Prediction of Fluid Responsiveness in Patients With Shock
- ClinicalTrials.gov ID
- NCT03276364
- Acronym / sponsor ID
- 206-13
- Conditions
- Ultrasound, Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Beth Israel Medical Center
- Study start
- 21 Jul 2014 (actual)
- Primary completion
- 17 Apr 2015 (actual)
- Study completion
- 17 Apr 2015 (actual)
- First posted
- 8 Sep 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.
Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness.
In this prospective, observational study, pulmonary and critical care fellows are asked to make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre- and post-ultrasound assessments are compared using a bioreactance monitor and passive leg raise test as the gold standard of fluid responsiveness in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shock | – | Diagnostic Test: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Could undergo both a POCUS and bioreactance assessment within 6 hours of admission from the emergency department or transfer from a medical floor. * Shock was defined as either systolic blood pressure less than 90 mmHg or 40 mmHg below baseline, necessity for vasopressors to maintain mean arterial pressure greater than 65 mmHg, or any evidence of acute organ hypoperfusion that was evident at the time of study enrollment as judged by the treating physician. * The patient needed to be in shock at the time of POCUS and bioreactance testing at time of enrollment in order to be included.
Key inclusion criteria (1 listed)
- Adults age 18 or older admitted to the MICU with a diagnosis of shock while a fellow was on duty.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| UltrasoundPoint-of-care ultrasound examination by pulmonary and critical care fellow | Diagnostic test | Shock |
Primary outcome
Fluid responsiveness
Time frame: Immediately subsequent to performance of a point-of-care ultrasound exam
Increase of stroke volume index greater than 10% following passive leg raise testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Shock, run by Montefiore Medical Center.
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 1 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: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid responsiveness (time frame: Immediately subsequent to performance of a point-of-care ultrasound exam). 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 8 Sep 2017.