Condition category
Circulatory System
Date applied
24/05/2017
Date assigned
01/06/2017
Last edited
31/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
During cardiac surgery, patients are monitored to evaluate cardiac function. In patients scheduled for cardiac surgery this usually includes either the use of a pulmonary arterie thermodilution catheter (PAC) or endotracheal echocardiography. At the time the study was conducted PAC was the golden standard. Newer devices have come out that need research in order to ensure that they are accurate and precise at measuring cardiac output. The aim of this study is to compare the AesculonTM bioimpedance electrical cardiometry (Aesc) to the pulmonary artery thermodilution catheter (PAC) technique before, during and after cardiac surgery.

Who can participate?
Adults aged 18 and older who are scheduled for cardiac surgery.

What does the study involve?
Participants who are undergoing cardiac surgery are randomly selected to participate in this study. After induction of anaesthesia, a PAC and the AesculonTM device are placed on the participant. Participants are measured using the standard pulmonary artery catheter and a thoracic electrical bioimpedance monitor. They have four additional electrodes placed on their neck and chest. Data from the monitors are recorded at certain time points to measure the accuracy and precision of the PAC compared to the Aesc.

What are the possible benefits and risks of participating?
There are no benefits or risks with participating.

Where is the study run from?
Maastricht University Medical Centre (Netherlands)

When is the study starting and how long is it expected to run for?
November 2008 to November 2010

Who is funding the study?
Maastricht University Medical Centre (Netherlands)

Who is the main contact?
Mr Boris Cox
b.cox@mumc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mr Boris Cox

ORCID ID

http://orcid.org/0000-0001-5906-3792

Contact details

Maastricht Universitair Medisch Centrum
P. Debyelaan 25
PB 5800
Maastricht
6202 AZ
Netherlands
+31 43 38765606
b.cox@mumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEC 08-4-075

Study information

Scientific title

Accuracy, precision and trending ability of electrical cardiometry cardiac output versus pulmonary artery thermodilution method: A prospective study

Acronym

Study hypothesis

The aim of this study is to compare the accuracy, precision and trending ability of a thoracic bioimpedance technique with pulmonary artery thermodilution before, during and after surgical intervention

Ethics approval

Institutional review board of the Maastricht University Medical Center, 15/12/2008, ref: MEC 08-4-075

Study design

Prospective observational study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Measurement of cardiac output with different devices in patients scheduled for cardiac surgery.

Intervention

After obtaining written informed consent of each patient, participants are randomly sampled from patients undergoing cardiac surgery. They receive the standard level of care during surgery. After induction of anesthesia, a pulmonary artery catheter (PAC) and the AesculonTM device are placed on the participant. The index test is a thoracic electrical bioimpedance cardiac output monitor (Aesculon, Osypka Medical, Berlin, Germany). The reference test was a pulmonary artery catheter (Edwards Life sciences Corporation, Irvine, CA, USA, Continuous Cardiac Output VIP catheter with SvO2, model 746F8).

The only difference to standard care was the placement of four additional electrocardiography electrodes. Two electrodes are placed in the neck and two are placed at the thoracic level. Only data from standard monitoring and bioimpedance were recorded. There were no benefits or risk for patients taking part in this observational study.

All measurements are performed at certain time points and there was no interference with standard care and monitoring. There was no need for follow up within this study group. Measurements are performed at six time points: after induction and prior to incision (T1), prior to cannulation of the aorta (T2), ten minutes after protamine administration (T3), 30 minutes after arrival in the ICU (T4), 1 hour after extubation (T5), and one day post-operatively at 08.00 AM (T6).

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Accuracy and precision are measured using Bland Altman analysis by comparing results from the clinical gold standard pulmonary artery catheter to the results from the new device, the bioimpedance cardiac output monitor at 6 time points, after induction and prior to incision, prior to cannulation of the aorta, ten minutes after protamine administration, 30 minutes after arrival in the ICU, one hour after extubation, and one day post-operatively.
2. Polar plot methodology was used to objectify trending ability of the new technique ( AesculonTM).

Secondary outcome measures

Our secondary aim was to assess whether the surgical incision, and therefore the interruption of the continuity of the skin of the thoracic cavity and opening of the cavity itself, could be an important factor in the reported discrepancy between the two instruments.

Overall trial start date

01/11/2008

Overall trial end date

12/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Scheduled for cardiac surgery
2. No contra-indication for the use of the pulmonary artery thermodilution method
3. Aged 18 and older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Contra indication for the use of the pulmonary artery thermodilution method
2. Under the age of 18

Recruitment start date

18/02/2009

Recruitment end date

18/12/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Maastricht University Medical Centre
Department of Anesthesiology and Pain Management Maastricht University Medical Center+ Maastricht Prof. Debylaan 25
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

Maastricht Universitair Medisch Centrum

Sponsor details

P. Debyelaan 25
PB 5800
6202 AZ Maastricht
Maastricht
6202 AZ
Netherlands
+31-43-3876543
secretariaat.metc@mumc.nl

Sponsor type

Hospital/treatment centre

Website

https://www.mumc.nl

Funders

Funder type

University/education

Funder name

Maastricht Universitair Medisch Centrum

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication with BioMed central.

IPD sharing statement:
The datasets generated during and analysed during the current study will be available upon request from Boris Cox at b.cox@mumc.nl

Intention to publish date

30/09/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes