Coronary Artery Bypass Graft Clinical Trial
Official title:
Impact of High Frequency Ventilation During Coronary Anastomosis in Off Pump Coronary Artery Bypass.
This study is to test the safety of high frequency-low volume ventilation during off pump coronary artery bypass as reflected in the near infrared spectroscopy values for cerebral oxygenation.
Ventilatory protocol: Patients will be randomized to either the apnea group or the HFV
group. In the HFV group the patients will be ventilated using a tidal volume of 1.5 ml per
kg and a respiratory rate of 100 per minute for as long as the surgeon needs to perform the
distal anastomosis of the coronaries.The same surgeon will perform all surgeries. In the
Control group, ventilation will be stopped for the duration of the anastomosis as it's done
currently. At all other times during the surgery, the ventilatory parameters will be
adjusted to maintain a PaCO2 between 40 and 45 mmHg.
The anesthesia protocol for the off pump coronary artery bypass will be as follows:
premedication will be left at the discretion of the anesthesiologist. In the operating room,
the patient will be instrumented with a radial arterial line before induction. Induction
will consist of a bolus of 1.0 mcg per Kg of Sufentanil. Anesthesia will be maintained with
1mcg per Kg per hour of Sufentanil. One per cent Isoflurane will be used as hemodynamic
parameters allow. Rocuronium 0.7 mg per Kg will be used to facilitate endotracheal
intubation. Following endotracheal intubation the patients will monitored with a pulmonary
artery catheter and a femoral arterial line. A perfusionist will be on standby at all times
for possible conversion to extracorporeal circulation.
Measures to effect:
Routine baseline laboratory investigations will be performed at admission of the patient to
the ward.
Hemodynamic parameters:
Arterial blood pressure, heart rate, pulmonary artery pressure, right ventricular pressure
will be recorded five minutes intervals throughout the surgery.
Ventilatory parameters and blood gases:
End tidal CO2 and pulse oxymetry will be recorded at five minutes intervals throughout the
surgery.
Arterial blood gases will be performed after induction, before and after each distal
coronary anastomosis and when judged necessary. The type and time for each anastomosis will
be noted.
C-reactive protein and brain natriuretic peptide:
Measurements of CRP and BNP will be perform at admission, after induction of anesthesia, in
the intensive care unit after the surgery and 24 hrs after admission to the intensive care
unit.
We will use the serum for measure of CRP.CRP will be measured using the Dade Behring N High
Sensitivity CRP assay (Dade Behring Diagnostics,Marburg,Germany) on the BN ProSpec
Nephelometer (Dade Behring Diagnostics).The assay will use monoclonal anti-CRP antibodies
coated to polystyrene particles and a human calibrator traceable to the WHO reference
material. We will use the Heparinised Plasma for measure of NT Pro-BNP.NT Pro-BNP will be
measure by electrochemiluminescence immunoassay using the Roche Pro BNP assay (Roche
Diagnostics , Mannheim,Germany) on the ElecSys 2010 analyzer (Roche Diagnostics).This assay
will use two polyclonal antibodies in a sandwich format.
Cerebral Oximetry Monitoring:
Cerebral oxymetry (rSO2) using near infrared spectroscopy (NIRS, Invos 5100; Somanetics
Corporation, Troy, MI) will be performed on all patients. After cleaning adjacent skin area
with alcohol, an adhesive optode pad will be placed over each front-temporal area. Resting
baseline rSO2 values will be obtained after waiting at least 1 min after placement of
sensors once values had stabilized, with patient resting quietly and receiving 3-5 L of
O2/min by nasal cannula. Continuous rSO2 values will be store on a floppy disk with a 15 s
update for the duration of the intraoperative period. With application of the chest
dressing, and before leaving the OR, monitoring will be discontinued and optodes will be
removed.
Transesophageal echocardiographic (TEE) measurements:
A comprehensive TEE examination will be performed for all patients as it's done
routinely(25). Specific TEE measurements as recommended be the ASE will be perform before
and after distal coronary anastomosis(26). RVMPI will be defined as the sum of isovolumic
contraction time and isovolumic relaxation time divided by the ejection time and the normal
value is 0.28±0.04). RV MPI will be measured using both pulse wave and tissue Doppler
imaging from a deep transgastric view and upper esophageal view. Right ventricular FAC %
will be measure in 4 chambers view and calculated as RV change in area in diastole minus RV
change in area in Systole divided by the calculated RV area in Diastole (37).
Analysis of HR and BP variability:
Baseline HR and BP variability will be analysed using wavelet transformation (27). The
extraction of characteristic frequencies, or specific oscillations, of a signal that is
composed of the consecutive R-R intervals for HR variability analysis, or consecutive
systolic blood pressures for BP variability analysis, is used. The analysis will be made
using MATLAB® and the dedicated toolbox software Wavelab. High frequency power of the HR
variability is indicative of changes in parasympathetic nervous system. Total power of the
BP variability signal is used as a measure of sympathetic outflow.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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