NCT01847859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

May 2, 2013

Last Update Submit

November 5, 2021

Conditions

Cardiothoracic Surgery

Keywords

Cardiothoracic surgeryPost-operativeNursesCardiacEchocardiographyPocket-sizeHand-held

Outcome Measures

Primary Outcomes (2)

  • 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

  • Reliability

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

    0 days

Secondary Outcomes (1)

  • Time use

    0 days

Other Outcomes (1)

  • Clinical impact

    0 days and 30 days

Study Arms (1)

Ultrasound performed by nurses

EXPERIMENTAL

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

Procedure: Ultrasound examination by nurses

Interventions

Ultrasound examination by nursesPROCEDURE

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

Also known as: Ultrasound
Ultrasound performed by nurses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Post-operative cardiothoracic patients admitted to the cardiac unit at the local hospital

You may not qualify if:

  • Not able or not willing to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medicine, Levanger Hospital, Nord-Trøndelag Health Trust

Levanger, 7601, Norway

Location

Related Publications (1)

  • 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.

    PMID: 25611808DERIVED

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 7, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 9, 2021

Record last verified: 2021-11

Locations

NO(1)