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Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery (Niccomo-Card)

U

University Hospital, Rouen

Status

Unknown

Conditions

Surgery
Output, Low Cardiac
Shock, Cardiogenic

Treatments

Device: Niccomo

Study type

Observational

Funder types

Other

Identifiers

NCT04643509
2019/020/OB

Details and patient eligibility

About

Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications.

Cardiographic bioimpedencemetry (Niccomo device, Imedex Corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. Nevertheless, the reliability of this device has been little studied after cardiac surgery.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age > 18 y/o
  • Patients benefiting from cardiac surgery AND pulmonary arterial catheter monitoring

Exclusion criteria

  • Aortic regurgitation grade 3-4
  • Uncontrolled Hypertension (MAP > 130 mmHg)
  • Circulatory or cardiac assistance
  • Active pacemaker

Trial design

100 participants in 1 patient group

cardiac surgery
Description:
patients benefiting from pulmonary arterial catheter monitoring after cardiac surgery
Treatment:
Device: Niccomo

Trial contacts and locations

1

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Central trial contact

Emmanuel Besnier, MD PhD

Data sourced from clinicaltrials.gov

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