Cardiopulmonary FailureNCT01723176
Evaluation of Ultrasound of the Heart in Patients With Low Blood Pressure
An observational study of Cardiopulmonary Failure, run by Northwell Health at 1 site in United States.
Trial summary
Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent to that of echocardiography technicians/cardiologists for the purpose of determining etiology (reason) of cardiopulmonary failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Failure
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to May 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the medical intensive care unit with cardiopulmonary failure
Who may be able to join
- Patients who present to the medical intensive care unit with cardiopulmonary failure
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Jewish Medical Center
New Hyde Park, New York, 11042
About this study
Official title: Evaluating Critical Care Echocardiography in Patients With Cardiopulmonary Failure at the Time of Presentation
Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent to that of echocardiography technicians/cardiologists for the purpose of determining etiology (reason) of cardiopulmonary failure.
- Conditions
- Cardiopulmonary Failure
- Being tested
- Echocardiography
- Keywords
- goal-directed echocardiography, cardiopulmonary failure, critical care ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients in Cardiopulmonary Failure | patients in cardiopulmonary failure Receives: Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of left ventricular function
Will the assessment of left ventricular function by critical care physicians and echo techs be concordant?
Measured: within four hours of ICU admission
Secondary outcomes (1)
Presence of Pericardial Effusion and Severity
Will the presence of pericardial effusion and severity from critical care physicians and echo techs be concordant?
Measured: within 4 hrs of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: study never got off the ground, no pts ever recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary FailureStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Weiner, Northwell Health
- Investigators
- Justin Weiner, DO, Principal investigator, NS-LIJ Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723176
- Sponsor's protocol ID
- 11-408A
- Status last verified
- Sep 2015
- First submitted
- 1 Nov 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Critical Care Echocardiography in Patients With Cardiopulmonary Failure at the Time of Presentation
- ClinicalTrials.gov ID
- NCT01723176
- Acronym / sponsor ID
- 11-408A
- Conditions
- Cardiopulmonary Failure
- Keywords
- goal-directed echocardiography, cardiopulmonary failure, critical care ultrasound
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study never got off the ground, no pts ever recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Nov 2012 (estimated)
- 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.
Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent to that of echocardiography technicians/cardiologists for the purpose of determining etiology (reason) of cardiopulmonary failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in Cardiopulmonary Failure | – | Procedure: Echocardiographypatients in cardiopulmonary failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the medical intensive care unit with cardiopulmonary failure
Key inclusion criteria (1 listed)
- Patients who present to the medical intensive care unit with cardiopulmonary failure
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 |
|---|---|---|
| Echocardiography | Procedure or surgery | Patients in Cardiopulmonary Failure |
Primary outcome
Assessment of left ventricular function
Time frame: within four hours of ICU admission
Will the assessment of left ventricular function by critical care physicians and echo techs be concordant?
1 secondary outcome
Presence of Pericardial Effusion and Severity
Time frame: within 4 hrs of ICU admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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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.
Justin Weiner, DO principal investigator
NS-LIJ Health System
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 Cardiopulmonary Failure, run by Northwell Health at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 28 Sep 2015. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assessment of left ventricular function (time frame: within four hours of ICU admission). 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 28 Sep 2015.