Patient overview:†
- Born at 39 weeks, full-term baby
- 3400 grams at birth
- Transposition of the great arteries (TGA) initially found on critical congenital heart disease (CCHD) screening, acute kidney injury (AKI)
The first 24 hours
A critical journey of hope begins
Tia is a full-term baby who appears healthy immediately after birth so she and her mother enjoy a quiet day recovering on the well-baby floor. During routine testing, a pulse oximetry sensor is used to screen for critical congenital heart disease (CCHD) and Tia fails to produce passing numbers, concerning the care team. She moves to the NICU and awaits an echocardiogram.
Despite being on oxygen, Tia is becoming increasingly cyanotic, has weakening peripheral pulses, and has increased work of breathing. Her echocardiogram confirms a Transposition of the great arteries heart defect.
24 hours & after
Medical marathons and milestone moments
Tia and her parents prepare for intracardiac repair — the open-heart surgery that is required to correct the heart defect. The surgery is successful and Tia is monitored post-operation.
Tia’s doctors watch for a deterioration in renal function that frequently follows cardiac surgery using INVOS™ regional oximetry system. Despite maximal medical therapy, 48 hours post-surgery, acute kidney injury (AKI) is identified and immediately treated with pediatric continuous renal replacement therapy (pCRRT). Due to the immediate dialysis response, Tia is expected to have a full kidney recovery.
NICU solutions
Products that support patients and provide critical information to the clinical team
CCHD sceening
About one in every four babies born with a heart defect, has a critical congenital heart defect (CCHD).1 Babies with a CCHD need surgery or other procedures in the first year of life. In most states post-delivery CCHD screening is mandatory.
For Tia’s CCHD screening the nurse uses a Nellcor™ OxySoft™ SpO2 sensor for a +/-2% accurate pulse oximetry reading that meets CCHD screening guideline requirements. OxySoft™ sensors are used continuously throughout her stay to track desaturation and apnea events as well as to monitor her during the car seat check, ensuring proper blood oxygenation and heart rate even while her airway is slightly compressed.
Nellcor™ OxySoft™ SpO2 sensor
Our Nellcor™ OxySoft™ SpO2 sensor helps you stay connected to your patients and their data with bright LEDs on a flexible circuit. The OxySoft™ sensor is longer lasting, losing only 20% of its initial adhesiveness after 18 repositions. With these improved features the sensor is easy to peel apart and reposition, plus it has improved signal acquisition and faster time to post during simulated low perfusion and thicker tissue.3
- Clinical trials have demonstrated the value of Nellcor™ pulse oximetry in assisting clinicians in recognizing critical congenital heart defects (CCHD) or unwell babies.4,5,6
- Continual Nellcor™ pulse oximetry evidence shows effectiveness during the car seat challenge7
- Nellcor™ pulse oximeters and Multi-Parameter Monitors with OxiMax™ technology use cardiac-based signal processing technologies to deliver accurate, reliable SpO2 and pulse rate readings8
- 70% improvement in blocking bright ambient lights that cause dropouts compared to MaxN sensors in a bench evaluation
- OxySoft™ sensor adhesive is easy to peel apart if it gets stuck together
- 50% reduction in time to post in simulated neonatal low perfusion state compared to MaxN sensor9,10
The Nellcor™ pulse oximetry monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.
Clinical evidence
- Monitoring Oxygen Saturation and Heart Rate During Neonatal Transition. Comparison Between Two Different Pulse Oximeters and Electrocardiography.
- Summary: Monitoring Oxygen Saturation and Heart Rate During Neonatal Transition. Comparison Between Two Different Pulse Oximeters and Electrocardiography.
- Continuous Vital Sign Analysis for Predicting and Preventing Neonatal Diseases in the Twenty-First Century: Big Data to the Forefront.
Post-op monitoring
Regional oximetry-guided care and interventions may improve outcomes in post-operative patients by reducing blood transfusions,11 cognitive dysfunction,12 and length of stay.13
Post-operation, Tia’s neonatologist monitors her cerebral saturation with the INVOS™ 7100 regional oximetry system and INVOS™ infant regional oximetry sensors.
INVOS™ 7100 regional oximetry system
Designed to help quickly identify desaturation events and improve the clinician’s ability to intervene sooner. Because seconds matter.
- Clinically validated design and our proprietary algorithm allow INVOS™ technology to measure acute alterations in hemodynamics, regional oxygen saturation (rSO2), and oxygen metabolism — markers that can help identify physiological changes more quickly than other indicators.
- Patient can be assessed for adequate delivery and consumption of oxygen at the organ-specific, regional tissue bed.
- Near-infrared spectroscopy (NIRS) may assist with characterization of a hemodynamically significant patent ductus arteriosus (hsPDA) by measuring cerebral and renal saturation (Csat and Rsat) levels.14
INVOS™ infant regional oximetry sensors
A soft, small sensor designed for fragile neonatal skin for use anywhere on the body. INVOS™ infant regional saturation sensors are applied to the skin’s surface, and are user and patient friendly, making monitoring of ischemic threats to the brain and body possible. By reporting venous weighted regional hemoglobin oxygen saturation (rSO2) in tissue directly beneath the sensor, the INVOS™ technology reflects oxygen remaining after tissue demand has been met.
The INVOS™ 7100 regional oximetry system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.
AKI treatment
Acute kidney injury (AKI) is a frequent complication of cardiac surgery. Even minor degrees of postoperative AKI may increase the risk of morbidity and mortality.15
Tia’s postoperative AKI is treated with the Carpediem™ cardio-renal pediatric dialysis emergency machine. This temporary treatment supports her kidney function during recovery, and she is removed from dialysis within 48 hours. She is released to go home with full kidney function.
Carpediem™ cardio-renal pediatric dialysis emergency machine
The first of its kind, the Carpediem™ system offers a miniaturized extracorporeal CRRT specifically designed for fragile, low weight pediatric patients weighing 2.5 to 10 kgs.
- pCRRT system removes waste products and decreases excess fluid
- Closely monitors fluid balance: +/- 1 g high-precision scales17
- Enables use of small catheter sizes18
- Reduces blood cell and vessel damage while providing necessary and adequate diffusive clearances: 2–50 mL/minimum low blood flow rates16,17,19
Clinical evidence
- AKI in Hospitalized Children: Comparing the pRIFLE, AKIN, and KDIGO Definitions
- CA.R.PE.DI.E.M. (Cardio–Renal Pediatric Dialysis Emergency Machine): Evolution of Continuous Renal Replacement Therapies in Infants. A Personal Journey.
- Designing Technology To Meet the Therapeutic Demands of Acute Renal Injury in Neonates and Small Infants
- Developing a Neonatal Acute Kidney Injury Research Definition: A Report From the NIDDK Neonatal AKI Workshop
“Every year, about 7,200 babies are born in the United States with critical CHDs.20 These critical heart defects consistently lead to low levels of oxygen in a newborn. Pulse oximetry is easy to use and non-invasive, but a very important tool for screening our newborn patients for life threatening conditions. This commonplace practice can indicate the need for additional screening, which in turn saves tiny, but not insignificant, lives daily.”
– Neonatal nurse†
MORE Resoures
Clinical support
Support and partnerships
A supportive family for those first months of life
The NICU team is more than just a group of highly trained and specialized medical professionals. It’s a genuine smile at the sight of a milestone achieved. It’s an emotional and sometimes heartbreaking end to a shift. It’s a supportive shoulder and life coach to a concerned parent struggling with their new reality. It is a family. At Medtronic we strive to be more than just a medical technology company; we aim to be a supportive member of that family.
Clinical support
We offer online medical education and product training from our highly experienced clinical field representatives.
eLearning courses are available for many of our NICU products.
Hospital support
Medtronic offers an innovative and broad portfolio to support the NICU. Quality and sustainability are of utmost importance. We design our sensors, cables, monitors, ventilators, and dialysis products for seamless compatibility, durability, and ease of use – so you can put your focus on your patients not the devices.
We offer comprehensive, professional reimbursement services to secure and maintain coverage and payment.
Our partners
Our partnerships with societies and nonprofits that serve the NICU help drive research, community connection, and solutions to the specific challenges that are faced on a regular basis.
Our partners include:
† These narratives feature fictional patients, based on real clinical scenarios and product use. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. Changes in a patient’s disease and/or medications may alter the efficacy of the therapy, or product features. Results may vary.
1
Oster M, Lee K, Honein M, Colarusso T, Shin M, Correa A. Temporal trends in survival for infants with critical congenital heart defects. Pediatrics. 2013;131(5):e1502-8.
2
Based on head-to-head testing with MaxN – CSR 2021 0312v1 S20-12.
3
Internal head-to-head bench testing against MaxN.
4
Van Niekerk AM, Cullis RM, Linley LL, Zuhlke L. Feasibility of pulse oximetry pre-discharge screening implementation for detecting critical congenital heart lesions in newborns in a secondary level maternity hospital in the Western Cape, South Africa: The ‘POPSICLe’ study. S Afr Med J. 2016;106(8):817-821.
5
Arlettaz R, Bauschatz AS, Monkhoff M, Essers B, Bauersfeld U. The contribution of pulse oximetry to the early detection of congenital heart disease in newborns. Eur J Pediatr. 2006;165(2):94-98.
6
Oakley JL, Soni NB, Wilson D, Sen S. Effectiveness of pulse-oximetry in addition to routine neonatal examination in detection of congenital heart disease in asymptomatic newborns. J Matern Fetal Neonatal Med. 2015; 28(14):1736-1739.
7
1986: Willett LD, et al. J Pediatr. 1986;109(2):245-24813; 1993: Bass JL, et al. Pediatrics. 1993;91(6):1137-114114; 1995: Bass JL, et al. Pediatrics.; 1995;96(2 Pt 1):288-29015; 2001: Merchant JR, et al. Pediatrics. 2001;108(3):647-65216; 2005: Ojadi VC, et al. BMC Pediatr. 2005;5:2817; 2006 & 2009: Kinane TB, et al. Pediatrics. 2006;118(2):522-52718/ Kornhauser Cerar L, et al. Pediatrics. 2009;124(3):e396-40219; 2016: Smith RW, et al. Paediatr Child Health. 2016;21(1):16-2020
8
Nellcor™ pulse oximeters and OEM solutions with OxiMax™ technology use a cardiac-based signal processing technique referred to as Cardiac-Gated Averaging (CGA) to qualify the pulses in the oximetry waveform.
9
Internal head-to-head bench testing against MaxN.
10
Based on head-to-head testing with MaxN – CSR 2021 0312v1 S20-1.
11
Vretzakis G, Georgopoulou S, Stamoulis K, et al. Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial. J Cardiothorac Surg. 2013;8:145.
12
Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. Eur J Cardiothorac Surg. 2015;47(3):447-454.
13
Murkin JM, Adams SJ, Novick RJ, et al. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007;104(1):51-58.
14
Valerie Y. Chock, Laura A. Rose, Jeanet V. Mante, and Rajesh Punn. Near-infrared spectroscopy for detection of a significant patent ductus arteriosus.. Pediatric Research, 2016;80(5): 675-680.
15
Zappitelli M, Bernier PL, Saczkowski RS, Tchervenkov CI, Gottesman R, Dancea A, et al. A small post-operative rise in serum creatinine predicts acute kidney injury in children undergoing cardiac surgery. Kidney Int. 2009;76:885-92.
16
Ronco C, Garzotto F, Ricci Z. CA.R.PE.DI.E.M. (Cardio-Renal Pediatric Dialysis Emergency Machine): evolution of continuous renal replacement therapies in infants. A personal journey. Pediatr Nephrol. 2012;27(8):1203–1211.
17
Carpediem™ dialysis system [Operator’s Manual]. Minneapolis, MN: Medtronic; 2021.
18
Vidal E, Cocchi E, Paglialonga F, et al. Continuous veno-venous hemodialysis using the Cardio-Renal Pediatric Dialysis Emergency Machine™: first clinical experiences. Blood Purif. 2018;31:1–7.
19
Garzotto, F, Zaccaria M, et al. Choice of catheter size for infants in continuous renal replacement therapy: Bigger Is not always better. Pediatric Critical Care Medicine. 2019;20(3): 170-179.
20
Adapted from Reller, MD, Strickland, MJ, Riehle-Colarusso, TJ, Mahle, WT, Correa, A. Prevalence of congenital heart defects in metropolitan Atlanta, 1998-2005. J Pediatr. 2008;153:807-13.