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In vivo study of pulse conductance of oxygenators during pulsatile flow


- candidate number3479
- NTR NumberNTR1346
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2008
- Secondary IDsMEC 08-2-036 ABR NL22896.068.08
- Public TitleIn vivo study of pulse conductance of oxygenators during pulsatile flow
- Scientific TitleIn vivo study of pulse conductance of oxygenators during pulsatile flow
- ACRONYMPulse Conductance of Oxygenators
- hypothesisThe objective of this clinical study is to endorse the hypothesis that oxygenators with a relatively high compliance and relatively low hydraulic resistance enable better pulse conductance than relatively stiff oxygenators featuring relatively high resistance.
- Healt Condition(s) or Problem(s) studiedOxygenator, Pulsatile flow, Heart-lung machine
- Inclusion criteria1. Patients scheduled for elective CABG using a standard heart-lung machine with either a standard used Maquet Quadrox HMO 2000 oxygenator, or a standard clinically equivalent Terumo Capiox SX18 oxygenator, using standard pulsatile perfusion at the university hospital Maastricht.
2. Calculated bypass flow of 5 l/min.
3. Written informed consent.
4. Age of 18 and older.
- Exclusion criteria1. All other patients that do not comply with the inclusion criteria given above, e.g. patients receiving valve surgery, or combined CABG / valve surgery.
2. No written informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2008
- planned closingdate31-dec-2008
- Target number of participants40
- InterventionsNon-interventional study, therefore non-applicable
- Primary outcomeTo measure pulse conductance of two standard types of oxygenators standard used during coronary artery bypass surgery using a standard heart-lung machine.
- Secondary outcomeTo measure/record the standard normalized index of haemolysis during elective coronary artery bypass surgery using a standard heart-lung machine.
- TimepointsBaseline measurement of free hemoglobin before initiation of cardiopulmonary bypass and after 30 min on cardiopulmonary bypass; continuous recording of line pressures after initiation of cardiopulmonary bypass.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Antoine P. Simons
- CONTACT for SCIENTIFIC QUERIES Antoine P. Simons
- Sponsor/Initiator University Hospital Maastricht (AZM), Department of Cardiothoracic Surgery
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM), Department of Cardiothoracic Surgery
- Publications
- Brief summaryRationale: The objective of this clinical study is to endorse the hypothesis that oxygenators with a relatively high compliance and relatively low hydraulic resistance enable better pulse conductance than relatively stiff oxygenators featuring relatively high resistance.

Objective: Primary objective: measure pulse conductance of two standard types of oxygenators standard used during coronary artery bypass surgery using a standard heart-lung machine.
Secondary objective: measure/record the standard normalized index of haemolysis during elective coronary artery bypass surgery using a standard heart-lung machine.

Study design: prospective controlled randomized observational study

Study population: 40 patients undergoing elective coronary artery bypass grafting (CABG) using extracorporeal circulation.

Intervention (if applicable): no intervention, standard CABG procedure only

Main study parameters/endpoints: Pulse conductance of the oxygenator used during pulsatile perfusion with a standard heart-lung machine, and the normalized index of haemolysis measured in relation to the oxygenator used during pulsatile perfusion with a standard heart-lung machine.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No other or additional risk than for those patients that do not involve in the study, and that undergo coronary artery bypass surgery. Differences in the two groups of standard oxygenators regarding primary and secondary objective is to be investigated. Both devices, however, have been clinically used for more than 15 years, and have been established as equivalent devices to take over lung function during heart surgery using extracorporeal circulation.

Regarding the results of the in vitro investigation in which the Quadrox had a better pulse conductance than the Capiox SX18, we expect a better pulse conductance in the Quadrox group in the clinical study as well. This would imply a less aggressive pulse generation in the Quadrox group, thus a reduced haemolysis. In standard clinical (non investigational) treatment, however, over the last 15 years, the haemolysis when using the Capiox SX18 oxygenator has not stood out. Therefore, we do not expect any complications in this group.
- Main changes (audit trail)
- RECORD17-jun-2008 - 25-jul-2008


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