Neuromonitoring in Patients During Aortic Valve Replacement
Nøkkelord
Abstrakt
Beskrivelse
Patients undergoing for aortic valve replacement will be enrolled in the study after giving the signed informed consent and will be divided in two groups depending on the type of the surgical technique. Either full sternotomy (FS) or minimal invasive sternotomy (MIS) will be performed, both with the use of cardio-pulmonary bypass (CPB).One week before and one week after the surgery patients will undergo mini mental test and measurement of visually evoked cerebral blood flow velocity response (VEFR).Levels of S100B, interleukin (IL) 1, IL 6, IL 8, IL 10 and microparticles will be determined before induction of anesthesia,as well as 6 h, 24 h, 48 h and 7 days after CPB.Each patient will have invasive and non invasive monitoring that will include near infrared spectroscopy (NIRS), bispectral index (BIS) and TCD during surgery.MES will be detected using TCD at the following time-points: beginning of surgery, after sternotomy, during aortic cannulation, during CPB, during de-airing, opening of the clamp on the aorta and after CBP removal before chest closure.All of this data will be documented as well as the demographic characteristics of patients, their preoperative medical status, and intraoperative data (duration of surgery, duration of CPB, hemodynamic parameters, inotropic/vasoactive support,blood and blood components); duration of mechanical ventilation in intensive care unit (ICU), duration of ICU stay, 30-day mortality and morbidity, as well as postoperative complications.
Datoer
| Sist bekreftet: | 09/30/2016 |
| Først sendt: | 01/24/2016 |
| Anslått påmelding sendt: | 02/24/2016 |
| Først lagt ut: | 03/02/2016 |
| Siste oppdatering sendt: | 10/26/2016 |
| Siste oppdatering lagt ut: | 10/27/2016 |
| Faktisk studiestartdato: | 12/31/2015 |
| Anslått primær ferdigstillelsesdato: | 11/30/2017 |
| Anslått sluttdato for studien: | 03/31/2018 |
Tilstand eller sykdom
Intervensjon / behandling
Device: Transcranial doppler
Fase
Armgrupper
| Væpne | Intervensjon / behandling |
|---|---|
| Active Comparator: AVR preformed with full sternotomy 30 patients, 7 days before and after surgery mini mental test and measurement of visual evoked cerebral blood flow response (VEFR) will be done.
Transcranial doppler measurements 1. beginning of the surgery, 2.after sternotomy, 3.during aortic cannulation,4.during CPB,5. during de-airing, 6. opening of the clamp on the aorta, 7. after CPB removal before chest closure. Prolonged de airing if needed | |
| Experimental: AVR preformed with minimal invasive sternotomy 30 patients, 7 days before and after surgery mini mental test and measurement of visual evoked cerebral blood flow response (VEFR) will be done.
Transcranial doppler measurements 1. beginning of the surgery, 2.after sternotomy, 3.during aortic cannulation,4.during CPB,5. during de-airing, 6. opening of the clamp on the aorta, 7. after CPB removal before chest closure. Prolonged de airing if needed |
Kvalifikasjonskriterier
| Alder Kvalifisert for studier | 18 Years Til 18 Years |
| Kjønn som kan studeres | All |
| Godtar sunne frivillige | Ja |
| Kriterier | Inclusion Criteria: - Isolated aortic valve stenosis as well as asymptomatic patients with depressed systolic function - Symptomatic patients with normal or depressed left ventricular function - Patients with American Society of Anesthesiologist (ASA) physical status classification 2 or 3 Exclusion Criteria: - History of brain stroke - EF less than 20% - History of alcohol abuse - Epilepsy of history of psychiatric illness and antipsychotic drugs - Patients with stenosis on carotid arteries - Patients with preformed surgery or already stented carotid arteries - Patients with poor or absent acoustic temporal window - Diagnosed dementia |
Utfall
Primære utfallstiltak
1. Detection of the intraoperative microembolic signals during minimal invasive sternotomy compared to full sternotomy with TCD during aortic valve surgery [Intraoperative detection:Beginning of surgery, after sternotomy, during aortic cannulation, during CPB, during de-aeration, opening of the clamp on the aorta and after CBP removal before chest closure.]
2. Detection of S100B serum protein, marker of brain tissue damage [Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB]
3. Detection of serum interleukin IL-1, IL-6,IL-8,Il-10 and Microparticles [Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB]
Sekundære utfallstiltak
1. Assessment of cerebrovascular reactivity using visually evoked cerebral blood flow velocity response (VEFR) measurements [7 days before and 7 days after surgery]
2. Assessment of neurologic and cognitive function in patients undergoing AVR [7 days before and 7 days after surgery]
Andre utfallstiltak
1. Length of ICU stay [Post operative period, an expected average of 2 days]
2. Requirement for inotropic and vasoactive therapy [1)After induction of anesthesia, 2)at the end of CPB ,3) postoperative period]
3. Duration of mechanical ventilation [postoperative period, an expected average 2 days]
4. 30 days mortality [30 days]
