Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery

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

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-09-30

Brief Summary

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The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

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Detailed Description

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At the present time, there is an increasing tendency to perform off-pump coronary artery bypass grafting (OPCAB). However, OPCAB poses a variety of challenges from the point of view of the anesthesiologist and the intensivist. The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

Conditions

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Coronary Artery Disease Hemodynamic Monitoring Goal Directed Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional monitoring

hemodynamic monitoring - conventional monitoring

Group Type ACTIVE_COMPARATOR

Conventional monitoring

Intervention Type DEVICE

In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)

Advanced monitoring

hemodynamic monitoring - advanced monitoring

Group Type ACTIVE_COMPARATOR

Advanced monitoring

Intervention Type DEVICE

In the AM group by the intrathoracic blood volume index, MAP, HR, central venous oxygen saturation (ScvO2) and cardiac index (CI). The measurements were performed before and during surgery, and at 2, 4 and 6 hrs post-operatively.

Interventions

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Conventional monitoring

In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)

Intervention Type DEVICE

Advanced monitoring

In the AM group by the intrathoracic blood volume index, MAP, HR, central venous oxygen saturation (ScvO2) and cardiac index (CI). The measurements were performed before and during surgery, and at 2, 4 and 6 hrs post-operatively.

Intervention Type DEVICE

Other Intervention Names

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Non actual PiCCO-CeVOX

Eligibility Criteria

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Inclusion Criteria

* Patients with coronary artery disease, ranked ASA II-III and scheduled for elective OPCAB

Exclusion Criteria

* Age \< 18 years
* Severe valve dysfunction or peripheral vascular disease
* Simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
* Transfer to CPB during surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No