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LOOPS study.


- candidate number9760
- NTR NumberNTR2941
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jun-2011
- Secondary IDsANES 2011/01 VUmc department of Anesthesiology
- Public TitleLOOPS study.
- Scientific TitleConstruction of intraoperative pressure-volume loops using transesophageal echocardiography and noninvasive beat-to-beat continuous finger blood pressure monitoring.
- ACRONYMLOOPS
- hypothesisIs 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) studiedIntraoperative cardiac monitoring, Left ventricular function
- Inclusion criteria1. 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 criteriaGroup 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 receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2011
- planned closingdate1-apr-2012
- Target number of participants20
- InterventionsBesides 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 outcomeIs 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 outcome1. 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?
- TimepointsAll measurement will take place in the operating room during surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R.A. Bouwman
- CONTACT for SCIENTIFIC QUERIESDr. R.A. Bouwman
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryIn 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)
- RECORD16-jun-2011 - 24-jun-2011


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