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Pocket-size Ultrasound by Nurses in Cardiothoracic Post-operative Patients

Sponsor
Helse Nord-Trøndelag HF (Other)
Overall Status
Completed
CT.gov ID
NCT01847859
Collaborator
Norwegian University of Science and Technology (Other)
59
Enrollment
1
Location
1
Arm
7
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound examination by nurses
 N/A

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

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Feasibility and Reliability of Routine Ultrasound Examination Performed by Nurses in Cardiothoracic Post-operative Patients
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ultrasound performed by nurses

Focused examination of the pleural and pericardial cavity. Cardiologists perform reference ultrasound examinations.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility and reliability [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.

    2. Reliability [0 days]

      Validation of ultrasound examinations and interpretation of the pleural and pericardial cavities by nurses compared with cardiologists as reference.

    Secondary Outcome Measures

    1. Time use [0 days]

      Comparison of the time use of ultrasound examinations of the pleural and pericardial cavities when examinations are performed by nurses and cardiologists, respectively.

    Other Outcome Measures

    1. Clinical impact [0 days and 30 days]

      Clinical influence of detection/assessment of pleural and pericardial effusion by ultrasound.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Post-operative cardiothoracic patients admitted to the cardiac unit at the local hospital
    Exclusion Criteria:
    • Not able or not willing to consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of medicine, Levanger Hospital, Nord-Trøndelag Health Trust Levanger Norway 7601

    Sponsors and Collaborators

    • Helse Nord-Trøndelag HF
    • Norwegian University of Science and Technology

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helse Nord-Trøndelag HF
    ClinicalTrials.gov Identifier:
    NCT01847859
    Other Study ID Numbers:
    • LH-2013-2
    • Spl postop hjerte
    First Posted:
    May 7, 2013
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Helse Nord-Trøndelag HF
    Cardiothoracic surgery
    Post-operative
    Nurses
    Cardiac
    Echocardiography
    Pocket-size
    Hand-held

    Study Results

    No Results Posted as of Nov 9, 2021