Ultrasound by Nurses in Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ultrasound examination by nurses
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Heart failure, Nurse led, Outpatient clinic, Echocardiography, Pocket-size, Ultrasound
Eligibility Criteria
Inclusion Criteria:
- Patients referred to the outpatient heart failure clinic at the local hospital
Exclusion Criteria:
- Not able or not willing to concent
Sites / Locations
- Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound performed by nurses
Ultrasound not performed
Arm Description
Examinations including ultrasound examinations
Examinations not including ultrasound examinations, otherwise active
Outcomes
Primary Outcome Measures
Treatment effect
Change in treatment after routinely performed ultrasound vs no ultrasound performed.
Secondary Outcome Measures
Quality of nurse performed ultrasound
Validation of nurse driven ultrasound. Measures of detection of volume state and specific ultrasonographic measurements compared to reference method (cardiologist performer ultrasound).
Full Information
NCT ID
NCT01794715
First Posted
February 13, 2013
Last Updated
November 5, 2021
Sponsor
Helse Nord-Trøndelag HF
1. Study Identification
Unique Protocol Identification Number
NCT01794715
Brief Title
Ultrasound by Nurses in Heart Failure Patients
Official Title
Is Routine Ultrasound Examination Performed by Nurses Useful in Heart Failure Patients at a Outpatient Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.
Detailed Description
Patient inclusion: Outpatient heart failure clinic. Patients are eligible for inclusion if the are referred with heart failure and concent to participate in the study. No other exclusion criteria other than no willing/able to give their concent.
Study population: Approximately 80 patients Intervention: All participants will undergo careful medical history, physical examination and blood tests led by nurses. All patients will be examined twice (by two nurses), one will routinely add ultrasound examination of the pleural space and the inferior vena cava to assess volume state, the other nurse will not perform ultrasound examination. Full cross-over design were nurses do ultrasound examinations at a random matter.
Patients will then be examined by echocardiography by experience cardiologist's echocardiographers. Outcome measures:Change in therapy after routinely performed ultrasound examinations vs controls, detection of volume state when performing ultrasound examinations compared to controls with cardiologist's echocardiographic examination as a gold standard.
Descriptive data of patients before, under and after examinations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Nurse led, Outpatient clinic, Echocardiography, Pocket-size, Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound performed by nurses
Arm Type
Experimental
Arm Description
Examinations including ultrasound examinations
Arm Title
Ultrasound not performed
Arm Type
Active Comparator
Arm Description
Examinations not including ultrasound examinations, otherwise active
Intervention Type
Procedure
Intervention Name(s)
Ultrasound examination by nurses
Other Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.
Primary Outcome Measure Information:
Title
Treatment effect
Description
Change in treatment after routinely performed ultrasound vs no ultrasound performed.
Time Frame
0 and 30 days and 6 months
Secondary Outcome Measure Information:
Title
Quality of nurse performed ultrasound
Description
Validation of nurse driven ultrasound. Measures of detection of volume state and specific ultrasonographic measurements compared to reference method (cardiologist performer ultrasound).
Time Frame
0 and 30 days and 6 months
Other Pre-specified Outcome Measures:
Title
proBNP vs ultrasound
Description
Study of which variable that best predicts the clinical treatment of the population
Time Frame
0 and 30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients referred to the outpatient heart failure clinic at the local hospital
Exclusion Criteria:
Not able or not willing to concent
Facility Information:
Facility Name
Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
City
Levanger
ZIP/Postal Code
7600
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
28320791
Citation
Gundersen GH, Norekval TM, Graven T, Haug HH, Skjetne K, Kleinau JO, Gustad LT, Dalen H. Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study. BMJ Open. 2017 Mar 20;7(3):e013734. doi: 10.1136/bmjopen-2016-013734.
Results Reference
derived
PubMed Identifier
26438785
Citation
Gundersen GH, Norekval TM, Haug HH, Skjetne K, Kleinau JO, Graven T, Dalen H. Adding point of care ultrasound to assess volume status in heart failure patients in a nurse-led outpatient clinic. A randomised study. Heart. 2016 Jan;102(1):29-34. doi: 10.1136/heartjnl-2015-307798. Epub 2015 Oct 5.
Results Reference
derived
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Ultrasound by Nurses in Heart Failure Patients
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