Monitoring of Cardiac Function With 3-axis Accelerometers

NCT ID: NCT01926067

Last Updated: 2015-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-04-30

Brief Summary

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Aim of the study: To validate accelerometers for continuous monitoring of global cardiac function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.

Detailed Description

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Hypothesis:

The following hypothesis will be tested: Accelerometer measures are clinical relevant indices of global left and right myocardial performance during weaning from cardiopulmonary bypass.

Model:

The performance of the accelerometer will be tested in a intraoperative setting, during weaning from cardiopulmonary bypass. Accelerometer measures of ventricular systolic and diastolic function will be compared to corresponding measures and indices of ventricular functions by echocardiography and hemodynamic monitoring during a step wise controlled weaning from cardiopulmonary bypass, ensuring precise control of pre- and afterload.

Conditions

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Heart; Surgery, Heart, Functional Disturbance as Result

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Significant aortic valvular disease scheduled to undergo cardiac surgery with an estimated extracorporeal circulation time \> 40 min.

Exclusion Criteria

* Evolving myocardial infarction,
* dyskinetic wall motions,
* cardiogenic shock,
* hepatic dysfunction or esophageal disease.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erik Fosse, Professor

Role: STUDY_DIRECTOR

Oslo University Hospital, The Intervention Sentre

Locations

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Oslo University Hospital, The Intervention Sentre

Oslo, , Norway

Site Status

Countries

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Norway

References

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Grymyr OH, Beitnes JO, Eidet J, Tollofsrud S, Fiane A, Skulstad H, Fosse E, Halvorsen PS. Detection of intraoperative myocardial dysfunction by accelerometer during aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Feb 1;24(2):188-195. doi: 10.1093/icvts/ivw326.

Reference Type DERIVED
PMID: 28364479 (View on PubMed)

Other Identifiers

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2011/2305 A (REK)

Identifier Type: -

Identifier Source: org_study_id

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