Plain English Summary
Background and study aims
During major abdominal surgery patients need to be monitored carefully to ensure that tissues have an adequate blood supply (perfusion) and level of oxygen (oxygenation). This requires monitoring of cardiac (heart) output and stroke volume (the volume of blood per beat) to determine the use of fluids and medication to improve blood pressure and flow. During operations the ideal monitor of cardiac output is as minimally invasive as possible. The aim of this study is to investigate a monitor that is non-invasive and compare it to a widely used minimal invasive monitor. The minimal invasive monitor (esophageal Doppler probe) requires an oral or nasal placed catheter (tube), and the non-invasive device (Aesculon) requires only four electrodes placed in the neck and thorax of the patient.
Who can participate?
Patients aged over 18 who are scheduled for elective major abdominal surgery
What does the study involve?
Under anaesthetic, the esophageal Doppler probe and the Aesculon device are placed on the participant. Cardiac output measurements are performed at eight time points: directly after the start of anaesthesia, after skin incision (cutting), during the surgical procedure when the patient is in a stable condition, after skin closure, just before extubation (removal of breathing tube), and 30 and 60 minutes after arrival in the recovery ward.
What are the possible benefits and risks of participating?
There is no interference with standard care and monitoring. The only difference to standard care is the placement of four additional electrodes.
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?
January 2009 to January 2010
Who is funding the study?
Maastricht University Medical Centre (Netherlands)
Who is the main contact?
Mr Boris Cox
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
6202AZ
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC 09-4-052
Study information
Scientific title
Accuracy, precision and trending ability of electrical cardiometry cardiac output versus esophageal Doppler: a prospective, observational study
Acronym
Study hypothesis
The aim of this study is to compare the accuracy, precision and trending ability of cardiac output measurements of a thoracic bioimpedance technique with esophageal Doppler, before, during and after major abdominal surgery.
Ethics approval
Institutional review board of the Maastricht University Medical Center, 20/07/2009, ref: MEC 09-4-052.2
Study design
Prospective observational study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Measurement of cardiac output with different devices in patients sheduled for major abdominal surgery
Intervention
Participants are randomly sampled from patients undergoing major abdominal surgery. They receive the standard level of care during surgery. After induction of anesthesia, a esophageal Doppler probe and the Aesculon 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 esophageal Doppler probe (CardioQTM, Deltex Medical, Chichester, United Kingdom), using the I2C 72-probe for nasal introduction.
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. 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 eight time points: (T1) directly after induction of anesthesia, (T2) after skin incision, during the surgical procedure when the patient was in a stable condition (T3, T4) were performed at a random moment, (T5) after skin closure, (T6) just before extubation, (T7) 30 minutes and (T8) 60 minutes after arrival on the recovery ward.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. Accuracy and precision is measured using Bland Altman analysis by comparing results from the esophageal Doppler to the results of the bioimpedance cardiac output monitor at the eight timepoints. The esophageal Doppler is validated against pulmonary artery catheter, the more or less gold standard of cardiac output measurement. So, the Doppler technique represents the gold standard in this study
2. Trending ability of the techniques is evaluated applying four-quadrant plot and polar plot methodology
Secondary outcome measures
Errors in bioimpedance measures are assessed using interruption of the skin's integrity and opening of the abdominal cavity by a surgical incision at the time of surgery
Overall trial start date
10/01/2009
Overall trial end date
07/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients scheduled for elective major abdominal surgery
2. > 18 years old
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 participants
Participant exclusion criteria
1. Nasal, pharyngeal, laryngeal or esophageal pathologies
2. Beeding disorders
3. Cardiac arrhythmias
4. Age < 18 years
5. No informed consent
Recruitment start date
25/08/2009
Recruitment end date
06/01/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Maastricht University Medical Centre
Department of Anesthesiology and Pain Management
MUMC+
P. Debyelaan 25
Maastricht
6202AZ
Netherlands
Sponsor information
Organisation
Maastricht Universitair Medisch Centrum
Sponsor details
p. Debyelaan 25
PB 5800
6202 AZ Maastricht
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
secretariaat.metc@mumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Maastricht Universitair Medisch Centrum
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submission of the paper is scheduled for October 2017 and publication for February/March 2018. Additional documents are available on request.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from P.B.W. Cox.
Intention to publish date
01/03/2018
Participant level data
Available on request
Basic results (scientific)
Publication list