Medico-Legal Risks – Page 2

Pneumothorax occurs in 1%-2% of normal-appearing healthy full-term newborn babies. However, in premature babies, it is much more common and dangerous. This condition may result in sudden respiratory status deterioration, and if not quickly recognized and treated, it may even lead to death. Furthermore, a history of pneumothorax in former preemies survivors is associated with less favorable outcomes. Medical management that contributed to pneumothorax, misdiagnosis, delayed diagnosis, improper treatment, delayed treatment - all may be reasons for medico-legal problems. I will briefly review essential information about pneumothorax and discuss in more detail when diagnosing this condition may have legal implications for providers and medical institutions. Pneumothorax in newborn babies - basic information Under normal circumstances, after we inhale air through our nose or mouth, air travels down the trachea (windpipe) into bronchi and their branches and, in the end, enters into millions of tiny air spaces called alveoli. In those alveoli, oxygen passes through cell walls into capillaries and attaches to red blood cells to be carried out to all our tissues. Sometimes, the smallest portions of our lungs rupture due to external factors, and air leaks outside the lungs, gathering between the chest wall and the lungs. In other words, air enters pleural space (pleural space = name of the space between the lung and chest wall). If only a tiny amount of air leaks, there is no trouble. However, if a significant amount of air gathers in the pleural space, it may restrict lung volume and their capacity to allow us to get enough air and oxygen into our bodies. Furthermore, such a condition is painful and may cause sudden blood pressure changes by compressing the heart. In severe cases, pneumothorax is associated with sudden deterioration of such parameters as oxygenation levels, heart rate, respiratory rate, and blood pressure. As a result of those sudden changes, premature babies will have a higher risk of intracranial bleeds (bleeding in the brain) and poor future neurodevelopment outcomes. A surveillance study performed on over 700 consecutively born babies showed that the incidence of pneumothorax in babies is 1%-2%. Most full-term babies do not have any symptoms or mild symptoms, and the disease is self-limited without any consequences. Pneumothorax is much more common among babies born prematurely with significant underlying respiratory conditions, especially if they require a CPAP machine or ventilator treatment (read also my article on respiratory care and malpractice in the NICU). Pneumothorax disorder is more frequent in babies with a diagnosis of Respiratory Distress Syndrome (RDS), Transient Tachypnea of Newborn (TTN), and Meconium Aspiration Syndrome (MAS). In 1999, Vermont Oxford Network (Association of high-risk NICUs in the world) published that the incidence of pneumothorax in over 26000 babies with birth weights between 500 gm - 1500 gm was 6.3%. This rate is lower now as we (neonatologists) have learned how to use better Surfactant (=medicine) and less invasive ventilation techniques. Once we suspect pneumothorax, the diagnostic approach should be fast and decisive. We can use three approaches to the diagnosis (source article): Physical examination by listening to breath sounds and finding decreased or uneven breath sounds on two sides Transillumination using a light - side with leaked air will "light up." Chest X-ray - should be requested immediately (STAT) In cases where the patient has deteriorated significantly (for example, the patient is in cardiorespiratory arrest), waiting for the X-ray may be unwise. Life-saving treatment procedures may need to be started immediately based only on suspicion of this diagnosis. Treatment approaches include watchful waiting, decompressing the chest using a needle, and, in severe cases, placing a chest tube inside the chest cavity for continuous air drainage. Patients with low oxygen levels will require supplemental oxygen by nasal cannula, CPAP machine, or ventilator (source article). The idea is to comfort the patient and return all vital signs and parameters to normal as soon as possible with minimal side effects or consequences. What are potential medico-legal issues if the newborn is diagnosed with a pneumothorax? Medical providers commit many mistakes while diagnosing and managing this condition. I will emphasize below the most common issues that I encounter in my work as a neonatal chart reviewer. For details that will help you in reviewing a neonatal chart consult this article. Did prior medical management contribute to the development of pneumothorax? We can conclude that pneumothorax could have developed iatrogenically (caused by providers) if a patient received mechanical ventilation and the ET tube (the breathing tube) was malpositioned or not checked quickly after insertion. Whenever a breathing tube ventilates only one lung, it may result in excessive pressure in that lung, leading to pneumothorax. Another situation where providers can contribute to this condition is if they use excessively high respiratory pressures on the ventilator when treating a patient with another respiratory disease. If misused, many settings that we dial on the ventilator may contribute to the development of the pneumothorax. Misdiagnosis As I mentioned above, diagnosis of pneumothorax relies on physical examination, transillumination, and chest x-rays. While we can suspect pneumothorax based on physical examination and transillumination, a chest X-ray is a gold standard for this diagnosis. It would be wrong to blame providers if, based only on the physical exam, they missed the diagnosis of pneumothorax or diagnosed it where there was no such condition. At the same time, providers would be wrong not to act on suspicion of pneumothorax even without certainty where the patient is rapidly deteriorating. We expect pediatricians, neonatologists, and radiologists to properly diagnose significant pneumothorax on chest X-rays. It is a diagnosis requiring sometimes urgent actions, and all these medical providers should have such competence. There is a report in the literature (I described this case report here) where the lack of the "side" marker on the X-ray indicating which side is right and left leads to the wrong diagnosis and subsequent placement of the chest tube on the wrong side. One should remember that the patient may also have "situs inversus" (liver on the left side); therefore, relying on the location of the liver and stomach bubble on the X-ray may sometimes be misleading. Delayed diagnosis We know that pneumothorax may be life-threatening. When a patient's condition is deteriorating rapidly, we do not have the luxury of waiting for a chest x-ray, for the radiologist to read it, or for a neonatologist to arrive in the hospital from home to evaluate and provide additional expertise. Furthermore, any deterioration of vital signs in a patient should prompt nurses to call medical providers for immediate bedside reevaluation and change in diagnostic approach and treatment if indicated. Improper treatment There are three acceptable approaches to managing pneumothorax. Watchful waiting for the resolution Needle aspiration of the air and conservative management Placement of chest tube for continuous drainage of the air We should always remember that the ultimate goal for the patient is to achieve normal oxygenation levels and stabilize vital signs. Whenever that goal is not attained, a question needs to be asked about whether therapy needs to be escalated further (source article). Here are a few examples: 1. If a patient is in cardiorespiratory arrest due to pneumothorax, such a patient will most likely need at least needle aspiration and, later, a chest tube. 2. If a patient is "just" OK on a ventilator with only partially expanded lungs and borderline blood pressure despite needle aspiration, such a patient probably needs a chest tube. 3. If a patient who had undergone needle aspiration now has a slight residual one-sided pneumothorax and is on a nasal cannula, with supplementary oxygen of 25% and all vital signs within normal limits comfortably breathing, we can continue watching that patient without any further interventions Delayed treatment In cases where a patient's vital signs are unstable (low blood pressure or low oxygenation levels despite supplementary oxygen), delaying treatment to wait for final confirmation of pneumothorax by a radiologist or even waiting to do an x-ray can not be justified. When I was in training a long time ago, my teacher used to tell me: "nobody dies without a chest tube." He meant that if a patient is severely ill and a diagnosis of pneumothorax is merely suspected, we must act on it without final confirmation by x-ray. We can not afford to wait in such a situation because needle aspiration or chest tube placement may save that patient's life. Should the patient be transferred to another hospital for a higher level of care? Whenever I review a case of a patient who developed pneumothorax, I try to find answers to two questions. Was it appropriate for an attending physician to keep this patient in a birth hospital after the baby's birth? We have four levels of hospitals in neonatal care. American Academy of Pediatrics published guidelines telling doctors what type of patients can be treated at each level. Certain premature babies or babies who require treatments on ventilators or CPAP machines for more than 8-12 hours should be transferred to level 3 or 4 NICUs. Should medical providers have transferred the patient to a higher level of care after diagnosis of pneumothorax and when the need for more aggressive treatment was identified? Lack of equipment or malfunctioning equipment There are rare situations, particularly in rural or small hospitals, where appropriate equipment to care for certain patients is unavailable or malfunctioning. Medical providers who find themselves in such cases end up improvising. Sometimes, they will use instruments more suitable for adults than babies, and other times, they can't provide the necessary life-saving procedures. Responsibility of the institution According to state and federal regulations, all institutions and their administrators are responsible to the public and prospective patients for providing necessary services. For example: 1. If you have delivery services, you are expected to have trained personnel to provide resuscitation to the baby if needed. 2. If you treat newborn babies with respiratory problems, you should have medical providers who know how to recognize and treat various complications in such patients. In smaller hospitals, a sudden pneumothorax in an infant requiring chest tube placement may occur only once every 2-3 years. Therefore, regular training to maintain skills is a must. 3. If you provide treatment to newborn babies with respiratory problems, it is expected that you will have the capability to perform X-rays in a timely manner 4. If you provide services to premature babies, you are expected to have the necessary equipment to do so. That includes all the equipment to treat pneumothorax correctly. In summary: Pneumothorax is a diagnosis that may be life-threatening for some newborn patients. Therefore, prompt diagnosis and proper treatments are crucial and expected to avoid harm. Unfortunately, many factors, such as its infrequency, lack of training, and inadequate staff or equipment, contribute to less-than-ideal outcomes in too many patients.