|- candidate number||28607|
|- NTR Number||NTR7030|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-feb-2018|
|- Secondary IDs||201800142 UMCG Research Register|
|- Public Title||Tracking fluid challenges during surgery|
|- Scientific Title||Tracking fluid challenges non-invasively with thoracic impedance cardiography derived CO and pleth variability index|
|- hypothesis||To assess the agreement of COqCO with reference CO values in patients under general anaesthesia in whom fluid is administered, as well as to study the influence of fluid administration on the ability of RPVI to reflect preload dependency. |
|- Healt Condition(s) or Problem(s) studied||Anesthesia, Pleth variability index, Thoracic impedance cardiography derived cardiac outpout|
|- Inclusion criteria||• Patients scheduled for elective non-cardiac surgery requiring invasive arterial blood pressure monitoring.|
• Patients older than 18.
• ASA physical status I-III.
• Informed and willing to give written informed consent.
|- Exclusion criteria||• Patients who refuse to participate.|
• Patients unable to consent (i.e. severe mental disorder, younger than 18).
• Patients with pacemakers.
• Patients with severe cardiac pathologies or hemodynamically unstable.
• Patients with end-stage renal failure.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2018|
|- planned closingdate||1-okt-2019|
|- Target number of participants||50|
|- Interventions||After induction of anaesthesia and once a steady state haemodynamic phase has been reached before incision, all patients will be administered 5ml kg-1 crystalloids i.v. in 5-10 minutes. The haemodynamic response will be evaluated by measuring COqCO, RPVI and the respective reference values, i.e. FloTrac/EV1000 TM derived CO and stroke volume variation (SVV), respectively. |
|- Primary outcome||The main study endpoint is the agreement of COqCO with reference CO in terms of bias, precision and trending ability. The change in RPVI will be assessed with respect to changes in SVV, to evaluate the ability of RPVI to track fluid-induced changes in preload dependency. |
|- Secondary outcome||- Analysis of the variability of qCO derived CO during the different hypnotic conditions of the patient (awake, anaesthetic induction phase, steady state general anaesthesia). |
- Comparison of the prediction of fluid responsiveness by RPVI with both FloTrac/EV1000-derived SVV and traditional PVI.
- Ability of RPVI to predict fluid responsiveness, defined as an increase in CO > 15%, and comparing it with the ability of SVV to predict fluid responsiveness.
|- Timepoints||From start of induction of anesthesia until end of surgery.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| R. Spanjersberg|
|- CONTACT for SCIENTIFIC QUERIES|| R. Spanjersberg|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||Technologic advances allow cardiac output (CO) to be monitored completely noninvasively using impendance cardiography (COqCO). Also, cardiac preload dependency can be assessed noninvasively using variations in plethysmography (RPVI). In patients under general anaesthesia in whom fluid is administered, the agreement of COqCO with clinical reference CO values is unknown, as well the ability of RPVI to assess changes in preload dependency. |
|- Main changes (audit trail)||No amendment, but additional information about the trial: |
Control group: active
|- RECORD||19-feb-2018 - 12-mrt-2018|