Now, there is finally a way to detect and remove air automatically and avoid the long term clinical complications, extended hospital stays and medical liability costs associated with air embolisms.
ClearLine IV defends patients against the dangerous intrusion of air during vascular access for delivering fluids, medication, blood or blood products using an intravenous or central line. This is the first, FDA-cleared device for the automatic detection and removal of air from fluid lines.
Patients in the Pediatric Intensive Care Unit (PICU) are extremely vulnerable to the clinical consequences of air inadvertently delivered through IV lines. The consequences of air breaking the fluid path are serious adverse clinical events often in the heart and lungs such as tachycardia or tachypnea. Any systemic venous air may cause a paradoxical arterial embolism through an intracardiac shunt or pulmonary arteriovenous malformation. Air also may traverse the pulmonary vascular bed even without a demonstrable shunt.1 A sudden drop in blood pressure may be indicative of an air mass entrainment.
An infant with small organs, fewer alveoli and a blood volume of about 1 L (80–90 mL/kg) cannot tolerate even tiny amounts of intravascular air. [Symptomatic venous air embolisms with only 0.4 mL/kg have been reported in infants.2]
In young infants with a persistent patent ductus arteriosus or a patent foramen ovale, right-to-left shunting is enhanced by increased central venous pressure and all organs may be affected including the brain, kidneys, intestinal tract and coronary arteries. Cerebral arterial gas embolus cause seizures, focal neurological deficits, depressed consciousness and lethal cardiac arrhythmia. The possibility of right-to-left shunting is much higher in neonates and infants when relative right and left atrial pressure differences are the lowest.3
Multiple medication and fluid lines placed in an infant or child through a complex network of IV sets, syringe pumps, warmers and injection ports lends itself to be in a higher risk for undetected air masses. Manual intervention for most syringe pumps on the market increases fatal risks for patients. ClearLine IV offers even the most vulnerable patients an automatic, reliable solution that prevents air from entering a pump, syringe pump, hand syringe or IV bag.1 Matthew W. Sowell, J.D., Cari L. Lovelady, M.D., B.G. Brogdon, M.D., and Cyril H. Wecht, M.D., J.D. Infant Death Due to Air Embolism from Peripheral Venous Infusion. J Forensic Sci, January 2007, Vol. 52, No. 1 doi:10.1111/j.1556-4029.2006.00307.x
Vascular air embolism is a potentially life-threatening event routinely encountered in patient care areas as well as the operating rooms. Left undetected and untreated in the operating room, iatrogenic air embolisms can become lethal.1
Air, which might not be detected visually, often enters the vasculature through empty IV bags, bag changes and syringe delivering medication. IV pumps in use today have “alarms” for air masses larger than 50 mLs. They stop fluid flow to the patient until the air is manually removed and the pump reset, which is tedious and time consuming. None remove air. Current syringe pumps neither detect nor remove air, which increases patient safety risks.
It also is well documented that fluid warmers can create air masses during the heating process and gradient temperature changes. Many market-leading warmers do not have effective air detection systems.2
An embolism may result in significant right ventricular outflow obstruction, leading to a decrease in cardiac output, hypotension, myocardial infarction, cerebral ischemia or possibly death. Even if the cardiac output remains above that required for adequate perfusion, the embolism may impart significant, adverse reactions. Air entrainment into the pulmonary circulation may lead to pulmonary vasoconstriction, release of inflammatory mediators, bronchoconstriction and an increase in ventilation/perfusion mismatch.1
The episodes of fluid-line venous air embolisms can be prevented with the ClearLine IV system. Having the constant vigilance as part of your standard Operating Room (OR) and Post-Anesthesia Care Unit (PACU) set ups will pro- tect patients from dangerous air intrusions in fluid lines.
1 Marek A. Mirski, M.D., Ph.D., Abhit Vijay Lele, M.D., Lunei Fitzsimmons, M.D., Thomas J. K. Toung, M.D. Diagnosis and Treatment of Vascular Air Embolism. Anesthesiology 2007; 106:164 –77
2 Warmer study
Patients in the Intensive Care Unit (ICU) may be vulnerable to even small amounts of air in their lines. The amount of air causing fatal venous embolisms ranges from 10-480 mLs. If the volume of the right side of the heart is the minimum space to be filled, about 100 mL can be accepted as a potentially fatal volume.1 While more than 5 mL ⁄ kg of air (IV) typically results in significant injury such as shock or cardiac arrest, patient complications may occur with as few as 20 mL of air.2
Designed to remove particles and susceptible to clogs and breaks, straight IV bag sets are a high risk for air masses. Many fluid-warmers and pressurized infusion devices have limited capabilities to detect and remove air during infusions. ClearLine IV is a patented system designed for automatic detection and removal of air masses as small as 25 mL. This accurately and reliably enables the transmission of fluids and vital medications for critical patients.
1 Department of Forensic Medicine & Toxicology, Government Medical College, Chandigarh 160030, India.
2 Department of Forensic Medicine & Toxicology, Vydehi Institute of Medical Sciences, Whitefield, Bangalore, Karnataka 560066, India.