|- candidate number||13383|
|- NTR Number||NTR3640|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-sep-2012|
|- Secondary IDs||2012/143 MEC UZ BRussel|
|- Public Title||Cardiac Effects of Thoracic Epidural Anesthesia in Clinical Conditions in Patients.|
|- Scientific Title||Cardiac Effects of Thoracic Epidural Anesthesia in Clinical Conditions in Patients.|
|- hypothesis||We aim to evaluate the effects of thoracic epidural analgesia on the heart function in human, both during general anaesthesia and mechanical ventilation during major abdominal or thoracic surgery or during one-lung ventilation. |
|- Healt Condition(s) or Problem(s) studied||Thoracic Epidural Anesthesia (TEA), One-lung ventliation, Cardiac effects|
|- Inclusion criteria||1. >18 years;|
2. Elective abdominal surgery;
3. Lung surgery with TEA.
|- Exclusion criteria||1. <18 years;|
2. Patients with altered heart, renal or lung function.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-okt-2012|
|- planned closingdate||1-okt-2013|
|- Target number of participants||80|
|- Interventions||Registration of images and measurements with TEE.|
|- Primary outcome||The use of TEA in patients undergoing Thoracic surgery.|
|- Secondary outcome||The use of TEA in patients with cardiac failure.|
|- Timepoints||1. After intubation;|
2. After loading of the TEA;
3. After each sequence of TLV and OLV.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Veerle Mossevelde, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Gudrun Ver Eecke|
|- Sponsor/Initiator ||Universitair Ziekenhuis Brussel|
(Source(s) of Monetary or Material Support)
|Universitair Ziekenhuis Brussel|
|- Brief summary||We aim to evaluate the effects of thoracic epidural analgesia on the heart function in human, both during general anesthesia and mechanical ventilation during major abdominal or thoracic surgery or during one-lung ventilation.
Eighty patients provided an 80% power to detect a two-tailed difference of 10% in echocardiographic parameters before and after TEA with an á error of 5% based on an expected standard deviation of 20%.|
Four different groups of patients will be studied. All these studies will be performed after approval by the Ethical Commission of the Universitair Ziekenhuis Brussel and written, informed consent of the patients.
Study I: Haemodynamic effects on normal lung-ventilation.
Study II: The effects on two and one-lung ventilation.
Study III: The effects of position during OLV.
Study IV: The effects of right versus left one-lung ventilation in supine position.
|- Main changes (audit trail)|
|- RECORD||27-sep-2012 - 18-okt-2012|