A comparison between cardiac output monitoring using (invasive) pulmonary artery catheter and (noninvasive) thoracic electrical bioimpedance

• Register: ISRCTN
• Last refreshed on: 30 April 2018
• Main ID: ISRCTN26732484
• Date of registration: 01/06/2017
• Prospective Registration: No
• Primary sponsor: Maastricht Universitair Medisch Centrum
• Public title: A comparison between cardiac output monitoring using (invasive) pulmonary artery catheter and (noninvasive) thoracic electrical bioimpedance
• Scientific title: Accuracy, precision and trending ability of electrical cardiometry cardiac output versus pulmonary artery thermodilution method: a prospective study
• Date of first enrolment: 18/02/2009
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN26732484
• Study type: Observational
• Study design: Prospective observational study (Diagnostic)

Countries of recruitment

Netherlands

Contacts

• Name: Boris Cox

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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).

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

MEC 08-4-075

Source(s) of Monetary Support

Maastricht Universitair Medisch Centrum

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 12/11/2010