Cardiothoracic SurgeryNCT01847859
Pocket-size Ultrasound by Nurses in Cardiothoracic Post-operative Patients
A study testing Ultrasound examination by nurses in people with Cardiothoracic Surgery, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial summary
The investigators aim to study the feasibility and reliability of pocket-size diagnostic ultrasound examinations performed by nurses of postoperative patients who have underwent cardiothoracic surgery in a cardiac unit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiothoracic Surgery
- What is being tested?
- Ultrasound examination by nurses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Dec 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-operative cardiothoracic patients admitted to the cardiac unit at the local hospital
Who cannot join
- Not able or not willing to consent
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Levanger, 7601
About this study
Official title: Feasibility and Reliability of Routine Ultrasound Examination Performed by Nurses in Cardiothoracic Post-operative Patients
The investigators aim to study the feasibility and reliability of pocket-size diagnostic ultrasound examinations performed by nurses of postoperative patients who have underwent cardiothoracic surgery in a cardiac unit.
Read the detailed description
Patient inclusion: Post-operative cardiothoracic surgery patients transferred to a cardiac unit. All such patients are eligible for inclusion if they consent to participate in the study. No other exclusion criteria other than not willing/able to give their consent. Only postoperative patients will be included.
Study population: Approximately 50 patients
Intervention: All participants will undergo careful medical history, physical examination and blood tests led by residents. All patients will routinely be examined with ultrasound by nurses trained in ultrasound examinations of the pleural space and the pericardium and a complete high-end echocardiography including assessment of both pleural cavities and the pericardial space will be performed in all by cardiologists.
Statistics and results: Feasibility and reliability will be studied.
- Conditions
- Cardiothoracic Surgery
- Being tested
- Ultrasound examination by nurses
- Keywords
- Cardiothoracic surgery, Post-operative, Nurses, Cardiac, Echocardiography, Pocket-size, Hand-held
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination by nursesProcedure or surgery
Also called Ultrasound
Focused examination of the pleural space and inferior vena cava.Reference method: Cardiologists performed ultrasound examinations.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound performed by nurses | Experimental | Focused examination of the pleural and pericardial cavity. Cardiologists perform reference ultrasound examinations. Receives: Procedure: Ultrasound examination by nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and reliability
Feasibility: Proportion of patients where the pleural and pericardial cavitis can be assessed and interpreted by ultrasound performed by nurses compared with cardiologists.
Measured: 0 days
Reliability
Validation of ultrasound examinations and interpretation of the pleural and pericardial cavities by nurses compared with cardiologists as reference.
Measured: 0 days
Secondary outcomes (1)
Time use
Comparison of the time use of ultrasound examinations of the pleural and pericardial cavities when examinations are performed by nurses and cardiologists, respectively.
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiothoracic SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847859
- Sponsor's protocol ID
- LH-2013-2
- Other IDs
- Spl postop hjerte
- Status last verified
- Nov 2021
- First submitted
- 2 May 2013
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Graven T, Wahba A, Hammer AM, Sagen O, Olsen O, Skjetne K, Kleinau JO, Dalen H. Focused ultrasound of the pleural cavities and the pericardium by nurses after cardiac surgery. Scand Cardiovasc J. 2015 Feb;49(1):56-63. doi: 10.3109/14017431.2015.1009383. Epub 2015 Feb 6.
PubMed 25611808
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
- Feasibility and Reliability of Routine Ultrasound Examination Performed by Nurses in Cardiothoracic Post-operative Patients
- ClinicalTrials.gov ID
- NCT01847859
- Acronym / sponsor ID
- LH-2013-2
- Conditions
- Cardiothoracic Surgery
- Keywords
- Cardiothoracic surgery, Post-operative, Nurses, Cardiac, Echocardiography, Pocket-size, Hand-held
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 May 2013 (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 investigators aim to study the feasibility and reliability of pocket-size diagnostic ultrasound examinations performed by nurses of postoperative patients who have underwent cardiothoracic surgery in a cardiac unit.
Detailed description
Patient inclusion: Post-operative cardiothoracic surgery patients transferred to a cardiac unit. All such patients are eligible for inclusion if they consent to participate in the study. No other exclusion criteria other than not willing/able to give their consent. Only postoperative patients will be included.
Study population: Approximately 50 patients
Intervention: All participants will undergo careful medical history, physical examination and blood tests led by residents. All patients will routinely be examined with ultrasound by nurses trained in ultrasound examinations of the pleural space and the pericardium and a complete high-end echocardiography including assessment of both pleural cavities and the pericardial space will be performed in all by cardiologists.
Statistics and results: Feasibility and reliability will be studied.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound performed by nurses | Experimental | Procedure: Ultrasound examination by nursesFocused examination of the pleural and pericardial cavity. Cardiologists perform reference ultrasound examinations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Post-operative cardiothoracic patients admitted to the cardiac unit at the local hospital
Key exclusion criteria (1 listed)
- Not able or not willing to consent
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 examination by nursesAlso: UltrasoundFocused examination of the pleural space and inferior vena cava.Reference method: Cardiologists performed ultrasound examinations. | Procedure or surgery | Ultrasound performed by nurses |
Primary outcome
Feasibility and reliability
Time frame: 0 days
Feasibility: Proportion of patients where the pleural and pericardial cavitis can be assessed and interpreted by ultrasound performed by nurses compared with cardiologists.
Reliability
Time frame: 0 days
Validation of ultrasound examinations and interpretation of the pleural and pericardial cavities by nurses compared with cardiologists as reference.
1 secondary outcome
Time use
Time frame: 0 days
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 9 Nov 2021.
- Derived from this study: PubMed 25611808Graven T, Wahba A, Hammer AM, Sagen O, Olsen O, Skjetne K, Kleinau JO, Dalen H. Focused ultrasound of the pleural cavities and the pericardium by nurses after cardiac surgery. Scand Cardiovasc J. 2015 Feb;49(1):56-63. doi: 10.3109/14017431.2015.1009383. Epub 2015 Feb 6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound examination by nurses in people with Cardiothoracic Surgery, 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 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 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 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?
Feasibility and reliability (time frame: 0 days). The study lists 2 primary outcomes in all. 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 NCT01847859, which also lists 1 linked publication.
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.