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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01847859
Other study ID # LH-2013-2
Secondary ID Spl postop hjert
Status Completed
Phase N/A
First received
Last updated
Start date May 2013
Est. completion date December 2013

Study information

Verified date November 2021
Source Helse Nord-Trøndelag HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Post-operative cardiothoracic patients admitted to the cardiac unit at the local hospital Exclusion Criteria: - Not able or not willing to consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound examination by nurses
Focused examination of the pleural space and inferior vena cava.Reference method: Cardiologists performed ultrasound examinations.

Locations

Country Name City State
Norway Department of medicine, Levanger Hospital, Nord-Trøndelag Health Trust Levanger

Sponsors (2)

Lead Sponsor Collaborator
Helse Nord-Trøndelag HF Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Clinical impact Clinical influence of detection/assessment of pleural and pericardial effusion by ultrasound. 0 days and 30 days
Primary 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. 0 days
Primary Reliability Validation of ultrasound examinations and interpretation of the pleural and pericardial cavities by nurses compared with cardiologists as reference. 0 days
Secondary 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. 0 days
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