The use of near infrared spectroscopy (NIRS) is a technique that has recently been incorporated by several other surgical specialties to measure tissue perfusion, such as in plastic surgery to allow for earlier detection of free flap vascular compromise in the postoperative monitoring protocol, with promising outcomes. IntraOx is a handheld oximeter that uses NIRS to measure tissue oxygen saturation and that has been used as an alternative to indocyanine green (ICG) to assess bowel perfusion in colorectal anastomotic cases. IntraOx is a promising technology that is also sterile and easy to use that can be incorporated into congenital heart surgery procedures to evaluate myocardial perfusion in a time sensitive manner. This technology could also be used on the liver to assess systemic perfusion as another indicator of cardiac function, in conjunction with the intraoperative transesophageal echocardiography (TEE). This could provide more concrete data about not only myocardial perfusion, but systemic perfusion as well. This data could be critical to help surgeons make surgical decisions and may help to improve patient outcomes. This will be a prospective review of the use of the Intra.Ox device during cardiac surgery at different timepoints during the procedure to assess perfusion. This device is FDA-approved for use in adults but not approved for use in children and will be investigational in children. The primary objective of this study is to test whether the Intra.Ox (Vioptix Inc.) using near-infrared spectroscopy to measure tissue oxygen saturation can be used to evaluate myocardial and visceral perfusion at different time points during complex congenital heart surgery, and particularly those involving coronary artery manipulation such as patients undergoing arterial switch operations or stage 1 palliation for hypoplastic left heart syndrome. The investigators would also use this device on the liver to assess systemic perfusion. The secondary objective is to evaluate whether the investigators would be able to use the information from the Intra.Ox device to make clinical decisions that can improve patient outcomes.
Study Type
OBSERVATIONAL
Enrollment
50
The Intra.Ox device will be used to measure %StO2 readings taken at different time points during the surgery, including: (1) prior to bypass when the heart is being perfused by the coronary arteries, (2) after the patient is placed on cardiopulmonary bypass (CPB) but prior to placing a cross-clamp, (3) after placing a cross-clamp when the heart is not being perfused by CPB, and (4) after the patient is taken off CPB and the heart is re-perfusing. These readings will not impact the surgical management of the patient, and the congenital heart surgery will be carried out per standard of care according to the judgement of the surgeon.
Oxygen saturation
Oxygen saturation levels measured from: pulse oximetry, tissue oximeter, arterial blood gases, and venous blood gases in units of %
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver function test: ALP
Post-operative liver function tests: Alkaline Phosphatase (ALP) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver Function Test: AST
Post-operative liver function test: AST (Aspartate Aminotransferase) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver function Test: ALT
Post-operative liver function test: ALT (Alanine Transaminase) in units of International Units per liter (U/L or IU/L) as a measure of the effects of systemic perfusion
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Cardiac function
Measuring cardiac function as measured by ejection fraction (in %) in post-operative echocardiogram results.
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Kidney function
Laboratory values of BUN and Creatinine (Cr) in units of mg/dL as a measurement of kidney function and perfusion
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Mortality and major complications
Major complications as defined by the STS and Congenital Heart Surgeons Society including renal failure requiring dialysis, permanent neurologic deficit, pacemaker, paralyzed diaphragm, mechanical circulatory support, and unplanned reintervention. This will be recorded as one outcome (whether or not a patient had mortality and major complications) and not measuring multiple multiple assessments; it is a quantitative assessment of whether or not a patient encountered one of the major complications or mortality as defined above. There are no units of measure.
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Lactate
Lactate levels in mmol/L as measurement for tissue perfusion.
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
pH
pH from arterial blood gas and venous blood gas to measure blood acidity/alkalinity.
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Blood gas: PaO2
PaO2 (partial pressures of oxygen) in mmHg from arterial and venous blood gas blood tests
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Blood Gas: PaCO2
PaCO2 (partial pressures of carbon dioxide) in mmHg from arterial and venous blood gas blood tests
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Bicarbonate
Bicarbonate values from arterial and venous blood gas in units of mmol/L. This is one outcome measure that will be recorded, not multiple assessments with different units of measure. Bicarbonate values will be recorded from two different blood gas sources in mmol/L.
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Echocardiography qualitative descriptions
Measurement and recording of qualitative written report from cardiologist interpretation of echocardiography, specifically assessing for reports of 1) valvular dysfunction (regurgitation or stenosis), 2) myocardial dysfunction, hypokinesis, filling defects, etc. or 3) any other abnormalities written in qualitative report relating to cardiac function
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Lactate
Lactate levels in mmol/L as measurement for tissue perfusion
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Intensive care unit length of stay
Intensive care unit length of stay in days
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Hospital length of stay
Hospital length of stay of stay in days
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver function tests: bilirubin
Measurements of bilirubin in units of mg/dL to assess liver function as indicator of tissue perfusion
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver function test: protein
Total protein in g/dL as measure of liver function
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Liver function test: albumin
Albumin in g/dL as measure of liver function
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: sodium
Basic metabolic panel laboratory value measuring sodium in units of mEq/L
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: potassium
Basic metabolic panel laboratory values measuring potassium in units of mEq/L
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: chloride
Basic metabolic panel laboratory values measuring chloride in units of mEq/L
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Electrolytes: CO2
Basic metabolic panel laboratory values measuring CO2 in units of mEq/L
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Basic metabolic panel: glucose
Basic metabolic panel glucose levels in units of mg/dL
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Basic metabolic panel: calcium
Basic metabolic panel calcium levels in units of mg/dL
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Aortic valve diameter
Aortic heart valve annulus diameters measured in mm
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Mitral valve diameter
Mitral valve annulus diameters measured in mm
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Pulmonary valve diameter
Pulmonary valve annulus diameters measured in mm
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Tricuspid valve diameter
Tricuspid valve annulus diameters measured in mm
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: aortic valve
Pressure gradients across aortic valve measured on echocardiography measured in mmHg
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: mitral valve
Pressure gradients across mitral valve measured on echocardiography measured in mmHg
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: tricuspid valve
Pressure gradients across tricuspid valve measured on echocardiography measured in mmHg
Time frame: Day 0 ("baseline") up to 2 weeks post-operation
Heart valve pressure gradient: pulmonic valve
Pressure gradients across pulmonic valve measured on echocardiography measured in mmHg
Time frame: Day 0 ("baseline") up to 2 weeks post-operation