Congenital Heart Disease
Conditions
Brief summary
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.
Interventions
DEVICETissue oximeter (IntraOx)
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.
Sponsors
Boston Children's Hospital
ViOptix Canada
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 1 year of age undergoing congenital heart surgery at Boston Children's Hospital are all eligible for participation in this study. * All subjects undergoing congenital heart surgery at Boston Children's Hospital will be screened for inclusion in this study. Screening will prioritize identifying patients with concern for decreased myocardial and peripheral perfusion for any reason, as designated by Dr. Sitaram Emani's clinical judgement. * Eligibility will be reviewed in advance by screening upcoming surgical procedures. All patients over 1 year of age will be eligible for participation in this study and screened for inclusion. Any patient at risk for malperfusion during bypass (e.g. Fontans, biventricular repair, long cross-clamp times, etc.) will be identified ahead of time and prioritized for inclusion in the study.
Exclusion criteria
* Any records flagged for "research opt out." * Neonates and children undergoing surgery less than 1 year of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation | Day 0 ("baseline") up to 2 weeks post-operation | Oxygen saturation levels measured from: pulse oximetry, tissue oximeter, arterial blood gases, and venous blood gases in units of % |
| Liver function test: ALP | Day 0 ("baseline") up to 2 weeks post-operation | 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 |
| Liver Function Test: AST | Day 0 ("baseline") up to 2 weeks post-operation | 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 |
| Liver function Test: ALT | Day 0 ("baseline") up to 2 weeks post-operation | 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 |
| Cardiac function | Day 0 ("baseline") up to 2 weeks post-operation | Measuring cardiac function as measured by ejection fraction (in %) in post-operative echocardiogram results. |
| Kidney function | Day 0 ("baseline") up to 2 weeks post-operation | Laboratory values of BUN and Creatinine (Cr) in units of mg/dL as a measurement of kidney function and perfusion |
| Mortality and major complications | Day 0 ("baseline") up to 2 weeks post-operation | 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. |
| Lactate | Day 0 ("baseline") up to 2 weeks post-operation | Lactate levels in mmol/L as measurement for tissue perfusion. |
| pH | Day 0 ("baseline") up to 2 weeks post-operation | pH from arterial blood gas and venous blood gas to measure blood acidity/alkalinity. |
| Blood gas: PaO2 | Day 0 ("baseline") up to 2 weeks post-operation | PaO2 (partial pressures of oxygen) in mmHg from arterial and venous blood gas blood tests |
| Blood Gas: PaCO2 | Day 0 ("baseline") up to 2 weeks post-operation | PaCO2 (partial pressures of carbon dioxide) in mmHg from arterial and venous blood gas blood tests |
| Bicarbonate | Day 0 ("baseline") up to 2 weeks post-operation | 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. |
| Echocardiography qualitative descriptions | Day 0 ("baseline") up to 2 weeks post-operation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive care unit length of stay | Day 0 ("baseline") up to 2 weeks post-operation | Intensive care unit length of stay in days |
| Hospital length of stay | Day 0 ("baseline") up to 2 weeks post-operation | Hospital length of stay of stay in days |
| Liver function tests: bilirubin | Day 0 ("baseline") up to 2 weeks post-operation | Measurements of bilirubin in units of mg/dL to assess liver function as indicator of tissue perfusion |
| Liver function test: protein | Day 0 ("baseline") up to 2 weeks post-operation | Total protein in g/dL as measure of liver function |
| Liver function test: albumin | Day 0 ("baseline") up to 2 weeks post-operation | Albumin in g/dL as measure of liver function |
| Electrolytes: sodium | Day 0 ("baseline") up to 2 weeks post-operation | Basic metabolic panel laboratory value measuring sodium in units of mEq/L |
| Electrolytes: potassium | Day 0 ("baseline") up to 2 weeks post-operation | Basic metabolic panel laboratory values measuring potassium in units of mEq/L |
| Electrolytes: chloride | Day 0 ("baseline") up to 2 weeks post-operation | Basic metabolic panel laboratory values measuring chloride in units of mEq/L |
| Electrolytes: CO2 | Day 0 ("baseline") up to 2 weeks post-operation | Basic metabolic panel laboratory values measuring CO2 in units of mEq/L |
| Basic metabolic panel: glucose | Day 0 ("baseline") up to 2 weeks post-operation | Basic metabolic panel glucose levels in units of mg/dL |
| Basic metabolic panel: calcium | Day 0 ("baseline") up to 2 weeks post-operation | Basic metabolic panel calcium levels in units of mg/dL |
| Aortic valve diameter | Day 0 ("baseline") up to 2 weeks post-operation | Aortic heart valve annulus diameters measured in mm |
| Mitral valve diameter | Day 0 ("baseline") up to 2 weeks post-operation | Mitral valve annulus diameters measured in mm |
| Pulmonary valve diameter | Day 0 ("baseline") up to 2 weeks post-operation | Pulmonary valve annulus diameters measured in mm |
| Tricuspid valve diameter | Day 0 ("baseline") up to 2 weeks post-operation | Tricuspid valve annulus diameters measured in mm |
| Heart valve pressure gradient: aortic valve | Day 0 ("baseline") up to 2 weeks post-operation | Pressure gradients across aortic valve measured on echocardiography measured in mmHg |
| Heart valve pressure gradient: mitral valve | Day 0 ("baseline") up to 2 weeks post-operation | Pressure gradients across mitral valve measured on echocardiography measured in mmHg |
| Heart valve pressure gradient: tricuspid valve | Day 0 ("baseline") up to 2 weeks post-operation | Pressure gradients across tricuspid valve measured on echocardiography measured in mmHg |
| Heart valve pressure gradient: pulmonic valve | Day 0 ("baseline") up to 2 weeks post-operation | Pressure gradients across pulmonic valve measured on echocardiography measured in mmHg |
Contacts
CONTACTSitaram Emani, M.D.
CONTACTVivian Nguyen, B.A.
Outcome results
None listed