An observational study in Peripheral Nerve Injuries and Thoracic Surgery, sponsored by Western University, Canada. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by Western University, Canada · Observational
PNI (Peripheral Nerve Injury) occurs in 5-15% of patients in cardiac surgery. So far, the mechanism of injury has never been researched. In this study, we will compare minimally invasive cardiac surgery with conventional cardiac surgery using a novel portable SSEP device to pinpoint the mechanism and timing of PNI during cardiac surgery.
General objectives The general objective of this study is to identify the causative insults during various kinds of cardiac surgeries. To attain this objective, we have three specific aims. Firstly, surgical insults such as excessive or asymmetric sternal retraction have long been regarded as the main causes of PNI. Therefore, we will investigate this by comparing cardiac surgeries with sternotomy to the ones without sternotomy. Secondly, more and more cardiac surgeons utilize minimally invasive techniques these days. In the current study, we will investigate the incidence, mechanisms and patterns of PNI in minimally invasive cardiac surgeries by comparing conventional surgeries to minimally invasive surgeries. Thirdly, recent studies have suggested systematic insults such as ischemia, inflammation, and underlying neuropathy might play more prominent roles in the mechanism of PNI. In this study, we will analyze various factors such as intraoperative hemodynamics and baseline patient characteristics to pinpoint the most responsible factors.
Background The studies regarding mechanisms of PNI in cardiac surgeries have not been done over the past few decades. With respect to minimally invasive cardiac surgeries, no studies have been done to investigate the mechanism of PNI.
Regarding the device used in this study The conventional SSEP device is large in size, invasive, and requires expertise to interpret. These characteristics have prevented its use in the operating room. This new portable SSEP device is devoid of these properties.
Significance Identification of causative insults will help clinicians to recognize and possibly prevent PNI during cardiac surgeries.
90 studies on the registry are indexed under Peripheral Nerve Injuries; 24 are open to participants now.
This study's planned enrollment of 100 is above the median of 63 across 24 observational studies indexed under Peripheral Nerve Injuries.
Browse Peripheral Nerve Injuries studies →Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Our inclusion criteria are all adult (age>18 years of age) cardiac surgical patients who are undergoing the four following procedures, open AVR, TAVI, conventional CABG, robotic CABG. This 4 groups of patients represent 4 different combination of potential surgical insults- median sternotomy, Internal thoracic artery (ITA) retraction, ITA harvesting, cardiopulmonary bypass and positioning
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●all adult (age>18, \<95 years of age) cardiac surgical patients who are undergoing the four following procedures, open AVR, TAVI, conventional CABG, robotic CABG
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transcatheter Aortic Valve Implantation
Conventional Valve Replacement
minimally invasive coronary artery bypass graft
Conventional Coronary Artery Bypass Graft
Cumulative duration of abnormal SSEP
Defined as the amplitude reduction \>50% from baseline, Latency\>10% from baseline
Time frame: From the beginning of the surgery to the end of surgery
The incidence of postoperative peripheral neuropathy at post-operative day 2-5
The incidence of postoperative peripheral neuropathy at Post-operative day (POD) 2-5, which is diagnosed based on neurological examination
Time frame: Post operative day 2 to 5
The number of SSEP abnormal alarms
The frequencies the SSEP devise sets off alarms
Time frame: From the beginning of the surgery to the end of surgery
Started Nov 2017 (actual). Primary completion is estimated for Dec 2018, 13 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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