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Hemodynamic monitoring with a disposable echoprobe.


- candidate number11188
- NTR NumberNTR3320
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2012
- Secondary IDs2011/214 MEC UZ Brussel
- Public TitleHemodynamic monitoring with a disposable echoprobe.
- Scientific TitleEvaluation of Feasibility of TEE Both Intraoperatively and Postoperatively.
- ACRONYMN/A
- hypothesisThis study aims to investigate the value and feasibility of a disposable TEE to monitor both fluid responsiveness and global contractile function of both left and right ventricles in high risk surgical patients, including both intraoperative management and postoperative follow up in a high dependency unit of a university hospital, against the information obtained from a non-invasive hemodynamic monitoring tool.
- Healt Condition(s) or Problem(s) studiedHemodynamic Monitoring, Fluid responsiveness, Contractile function of both left and right ventricles
- Inclusion criteriaAll patients (aged between 18 and 75 y) are scheduled for high-risk abdominal, gynecological, vascular or orthopedic surgery.
- Exclusion criteriaExcluded are those patients undergoing upper gastro-intestinal surgery with an impossibility to perform a TEE investigation. Also not enrolled are patients suffering from coagulopathy, or inability to insert a transesophageal probe for whatever medical reason.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-okt-2011
- planned closingdate1-jun-2012
- Target number of participants25
- InterventionsInsertion of an echoprobe in the oesophagus via nose. The tool is used solely for hemodynamic monitoring. The final diagnosis is performed by the attending anesthetist.
- Primary outcomeDiagnosis of fluid responsiveness and ventricular failure at the hereunder described timepoints.
- Secondary outcomeN/A
- TimepointsAfter induction of anesthesia, at each period of hemodynamic instability, before extubation, and in the postoperative phase on arrival in the high-dependency unit and every 4 hrs thereafter. Whenever hemodynamic instability occurs, an evaluation in addition will be performed.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J. Poelaert
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryIn a comparative prospective study a disposable TEE will be used to compare diagnosis of fluid responsiveness and ventricular failure in high risk surgical patients. The comparative monitoring will be a non-invasive haemodynamic monitor, providing beat-to-beat cardiac output and blood pressure variability (Nexfin).
- Main changes (audit trail)
- RECORD23-feb-2012 - 10-mrt-2012


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