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Perioperative validation of the non-invasive hemodynamic measuring device TL-400


- candidate number25626
- NTR NumberNTR6998
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2016
- Secondary IDs 
- Public TitlePerioperative validation of the non-invasive hemodynamic measuring device TL-400
- Scientific TitlePerioperative validation of the non-invasive hemodynamic measuring device TL-400
- ACRONYM
- hypothesisAre hemodynamic values obtained by the non invasive hemodynamic measuring device TL-400 comparable with the values obtained by the standard invasive hemodynamic measuring devices (transpulmonary thermodilution (TPTD) (PiCCO system; Pulsion Medical Systems) or pulmonary artery catheter (PAC)
- Healt Condition(s) or Problem(s) studiedMeasurement blood pressure, Measurement cardiac output , Hemodynamic changes, Fluid challenge, Non invasive cardiac output measurement
- Inclusion criteriaAll patients receiving invasive hemodynamic monitoring as standard perioperative monitoring are eligible for inclusion.
Age > 18 years
- Exclusion criteriaSevere peripheral vascular disease
Severe tricuspid or aortic valve regurgitation
Anatomical abnormalities at the wrist so the TL-400 brace cannot be applied.
Refusal of the patient
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate
- Target number of participants20
- InterventionsAfter insertion of the standard invasive measuring device, the TL 400 sensor is placed around the wrist at the point where the radial artery is palpable over the head of the os radius.
- Primary outcomeCardiac output, systolic blood pressure, diastolic blood pressure, mean blood pressure, stroke volume
- Secondary outcomenone
- Timepoints3 measurement during anaesthesia; after induction, during surgery prior to closure. 2 measurement before and after fluid challenge.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. L. Baggen
- CONTACT for SCIENTIFIC QUERIES Cor Slagt
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- Publications
- Brief summary
- Main changes (audit trail)Ontbrekende informatie niet aangeleverd door onderzoeker.
- RECORD2-dec-2016 - 8-feb-2018


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