|- candidate number||9760|
|- NTR Number||NTR2941|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jun-2011|
|- Secondary IDs||ANES 2011/01 VUmc department of Anesthesiology|
|- Public Title||LOOPS study.|
|- Scientific Title||Construction of intraoperative pressure-volume loops using transesophageal echocardiography and noninvasive beat-to-beat continuous finger blood pressure monitoring.|
|- hypothesis||Is it possible to construct intraoperative left ventricular end-systolic pressure-volume relations from a combination of non-invasive finger arterial blood pressure measurements and transoesophageal echocardiography in patients undergoing surgery?|
|- Healt Condition(s) or Problem(s) studied||Intraoperative cardiac monitoring, Left ventricular function|
|- Inclusion criteria||1. Patients scheduled for:|
A. Open abdominal surgery via laparotomy;
B. Cardiac surgery, Coronary Artery Bypass Graft.
2. Age 18-75 years;
3. Informed consent.
|- Exclusion criteria||Group A specific:|
1. Known / documented cardiac disease;
2. ECG / echocardiography abnormalities.
All subjects group A + B:
1. Contraindications for TEE;
2. Contraindications for arterial line;
3. Contraindications for administration of phenylephrine.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2011|
|- planned closingdate||1-apr-2012|
|- Target number of participants||20|
|- Interventions||Besides standard intraoperative monitoring, patients will receive the following:|
1. Transoesophageal echocardiography;
2. Continuous noninvasive finger blood pressure measurements using the Nexfin;
3. Inferior Vena cava occlusion for 15 seconds;
4. Administration of Fenylephrine intravenously.
|- Primary outcome||Is it possible to reconstruct intraoperative left ventricular end-systolic pressure-volume relations from a combination of non-invasive finger arterial blood pressure measurements and transesophageal echocardiography in patients undergoing surgery?|
|- Secondary outcome||1. What is the relation of dicrotic notch pressure in the aortic pressure curve to beat average pressure?|
2. Loading changes to construct the end systolic pressure-volume relation are commonly induced by reducing preload using inferior vena cava compression. Does increasing afterload using phenylephrine-induced vasoconstriction provide an alternative for inferior vena cava compression?
|- Timepoints||All measurement will take place in the operating room during surgery. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. R.A. Bouwman|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.A. Bouwman|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||In this study we will investigate a method combining transoesophageal echocardiography and non-invasive finger arterial blood pressure waveforms to non-invasively construct pressure-volume (P-V) loops to describe the end-systolic pressure-volume relations in the heart. This may provide a method to obtain more insight on cardiac contractile function and the interaction of the heart with the vasculature during surgery. |
|- Main changes (audit trail)|
|- RECORD||16-jun-2011 - 24-jun-2011|