Echocardiographic Examination Performed by Nurses in Card... | NCT00886548

Studies
Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit

NCT00886548

Sponsor

Helse Nord-Trøndelag HF

Status

Withdrawn

Last Update Posted

Nov 9, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Heart Failure
Myocardial Infarction
Pleural Effusion

Interventions

Ultrasound performed

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Delayed inclusion

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Apr 21, 2009

First Submission Date that Met QC Criteria

Apr 22, 2009

First Posted Date

Apr 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2021

Last Update Posted Date

Nov 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is:

To study the clinical usefulness of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
To study reproducibility of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
To study which ultrasound measure that best correlate with the amount of pleural effusion.

Detailed Description

For a period of 1 year patients in our cardiac intensive care unit will be recruited to nurse-drive ultrasound and echocardiographic examinations, after informed consent. Nurses underwent a training programme and their skills are approved by cardiologist. Our department does not always have a cardiologist on duty and indication for nurse-driven ultrasound examination is decided by the doctor responsible for the treatment, who not always are trained in echocardiography/ultrasound. We aim to study the described hypothesis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound performed		Single arm study.	Procedure: Ultrasound performed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound performed	Procedure	Nurse-driven ultrasound performed	Ultrasound performed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of diagnosis		6-12 months

Secondary Outcomes

Measure	Description	Time Frame
Change of treatment		6-12 months
Quantification of pleural effusion		6-12 months
Reproducibility of nurse-performed examinations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient at Cardiac intensive care unit, Levanger Hospital
Doctor responsible for treatment finds echocardiographic/ultrasound examination indicated.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients hospitalized at Cardiac Intensive Care Unit at Levanger Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Håvard Dalen, MD	Levanger Hospital, Nord-Trøndelag Health Trust	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Hospital of Levanger		Levanger		7600	Norway

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D009203	Myocardial Infarction
D010996	Pleural Effusion

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided