Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

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

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-09-30

Brief Summary

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The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed.

Detailed Description

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The thermodilution technique with a pulmonary artery catheter has been the standard in adult patients for cardiac output measurement. However, using pulmonary artery catheter remains a major clinical problem in children due to technical and size constraints.

COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by body-temperature isotonic saline injected into the central vein and calculates cardiac output derived from a dilution curve.

Conditions

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Post Cardiac Surgery

Keywords

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Cardiac output Perivascular Probe

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children \<15 kg admitted to pediatric cardiac surgery for corrective surgery and mechanically ventilated were eligible for the study if parents provided informed consent.

Exclusion Criteria

* Children with known significant tricuspid or mitral valve regurgitations or if it is detected by the preoperative transesophageal echocardiographic examination.
* Children with persistent severe arrhythmias.
* Children with remaining intracardiac shunts after surgery, which may adversely affect the measurement.

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Lindberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital in Lund

Locations

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Children Hospital, BUS, BIVA

Lund, , Sweden

Site Status

Countries

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Sweden

References

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Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.

Reference Type BACKGROUND

PMID: 18496416 (View on PubMed)

Other Identifiers

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IRB

Identifier Type: OTHER

Identifier Source: secondary_id

TSI-S-COstatus-13A-H

Identifier Type: -

Identifier Source: org_study_id