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Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery

NCT ID: NCT04643509

Last Updated: 2020-12-24

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-18

Study Completion Date

2022-12-23

Brief Summary

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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.

Detailed Description

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Conditions

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Shock, Cardiogenic Surgery Output, Low Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cardiac surgery

patients benefiting from pulmonary arterial catheter monitoring after cardiac surgery

Niccomo

Intervention Type DEVICE

Niccomo monitoring added to pulmonary arterial catheter monitoring

Interventions

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Niccomo

Niccomo monitoring added to pulmonary arterial catheter monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rouen University Hospital

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emmanuel Besnier, MD PhD

Role: CONTACT

Phone: +33232881705

Email: [email protected]

Facility Contacts

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emmanuel besnier, MD

Role: primary

Other Identifiers

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2019/020/OB

Identifier Type: -

Identifier Source: org_study_id