Heart FailureNCT00886548
Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit
An observational study of Heart Failure and Myocardial Infarction, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial summary
The purpose of this study is: To study the clinical usefulness of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit. To study reproducibility of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Heart Failure, Myocardial Infarction, Pleural Effusion
- What is being tested?
- Ultrasound performed
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2009to May 2010
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized at Cardiac Intensive Care Unit at Levanger Hospital
Who may be able to join
- Patient at Cardiac intensive care unit, Levanger Hospital
- Doctor responsible for treatment finds echocardiographic/ultrasound examination indicated.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit. Is it Clinical Useful?
The purpose of this study is:
- To study the clinical usefulness of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
- To study reproducibility of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
- To study which ultrasound measure that best correlate with the amount of pleural effusion.
Read the detailed description
For a period of 1 year patients in our cardiac intensive care unit will be recruited to nurse-drive ultrasound and echocardiographic examinations, after informed consent. Nurses underwent a training programme and their skills are approved by cardiologist. Our department does not always have a cardiologist on duty and indication for nurse-driven ultrasound examination is decided by the doctor responsible for the treatment, who not always are trained in echocardiography/ultrasound. We aim to study the described hypothesis.
- Conditions
- Heart Failure, Myocardial Infarction, Pleural Effusion
- Being tested
- Ultrasound performed
- Medical subject headings
- Heart Failure, Myocardial Infarction, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound performedProcedure or surgery
Nurse-driven ultrasound performed
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound performed | Single arm study. Receives: Procedure: Ultrasound performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of diagnosis
Measured: 6-12 months
Secondary outcomes (3)
Change of treatment
Measured: 6-12 months
Quantification of pleural effusion
Measured: 6-12 months
Reproducibility of nurse-performed examinations
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Delayed inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Håvard Dalen, MD, Study chair, Levanger Hospital, Nord-Trøndelag Health Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886548
- Sponsor's protocol ID
- SL-20091
- Status last verified
- Nov 2021
- First submitted
- 21 Apr 2009
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit. Is it Clinical Useful?
- ClinicalTrials.gov ID
- NCT00886548
- Acronym / sponsor ID
- SL-20091
- Conditions
- Heart Failure, Myocardial Infarction, Pleural Effusion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Delayed inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Apr 2009 (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.
The purpose of this study is:
- To study the clinical usefulness of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
- To study reproducibility of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
- To study which ultrasound measure that best correlate with the amount of pleural effusion.
Detailed description
For a period of 1 year patients in our cardiac intensive care unit will be recruited to nurse-drive ultrasound and echocardiographic examinations, after informed consent. Nurses underwent a training programme and their skills are approved by cardiologist. Our department does not always have a cardiologist on duty and indication for nurse-driven ultrasound examination is decided by the doctor responsible for the treatment, who not always are trained in echocardiography/ultrasound. We aim to study the described hypothesis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound performed | – | Procedure: Ultrasound performedSingle arm study. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized at Cardiac Intensive Care Unit at Levanger Hospital
Key inclusion criteria (2 listed)
- Patient at Cardiac intensive care unit, Levanger Hospital
- Doctor responsible for treatment finds echocardiographic/ultrasound examination indicated.
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 |
|---|---|---|
| Ultrasound performedNurse-driven ultrasound performed | Procedure or surgery | Ultrasound performed |
Primary outcome
Change of diagnosis
Time frame: 6-12 months
3 secondary outcomes
Change of treatment
Time frame: 6-12 months
Quantification of pleural effusion
Time frame: 6-12 months
Reproducibility of nurse-performed examinations
Time frame: 6-12 months
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 9 Nov 2021.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Håvard Dalen, MD study chair
Levanger Hospital, Nord-Trøndelag Health Trust
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 Heart Failure and Myocardial Infarction, run by Helse Nord-Trøndelag HF at 1 site in Norway.
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 2 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 9 Nov 2021. 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 Norway. 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?
Change of diagnosis (time frame: 6-12 months). 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 9 Nov 2021.