1. What is ARDS? Why am I being approached about this?
Acute Respiratory Distress Syndrome (ARDS) is a serious reaction to direct and/or indirect lung injury. It is characterized by inflammation of lung tissue which may lead to systemic organ failure and can be fatal. ARDS can occur within 24-48 hours or even up to a week after injury or acute illness, and requires intensive medical care. A less severe form of illness is acute lung injury (ALI), which is sometimes a precursor to ARDS development. You are being approached because you (as a patient or as a patient’s surrogate) are at risk for developing ARDS.
2. What are the risk factors for ARDS? What are the chances of developing it with these symptoms?
There are several risk factors that might lead to ARDS development. These include bacteremia (bacteria in the blood), sepsis (body-wide infection) and pneumonia (fluid in the lungs). These have the lowest risk for developing ARDS (up to 10%). However, some factors like septic shock (more severe form of sepsis that includes organ dysfunction), trauma (sudden physical injury), aspiration (foreign material in the lungs) or massive transfusion (receiving large amounts of donated blood), hold a higher risk (about 30%) for developing ARDS. While the chances of developing ARDS are not always high, we don’t understand why some people progress to ARDS and others do not.
3. How serious is ARDS? What will happen if ARDS develops?
It is a serious complication. A typical ARDS patient will probably be on a breathing machine (ventilator) for a while and will likely be in the hospital for a long time. About 40% of people who get it will die. We are trying to identify those who might be at higher risk for developing ARDS so we may treat them more effectively.
4. Can a person this sick spare the blood?
The amount of blood we are talking about is small compared to the amount you have in your body. We will take about 6 tablespoons of blood over a few days. It is no more than what a doctor normally orders for a routine physical and blood work. If a blood transfusion is needed later, it is because of the underlying illness, not participation in this study.
5. What are the risks to participating in this study?
The physical risk is minimal as this is an observational study (no intervention or medical treatment is delivered). We may take, with your explicit permission, blood, urine, lung fluid as part of a bronchoscopy, or exhaled breath condensate (the liquid found in the breathing tube, if one is used). With the exception of blood, the other fluids are considered excess or waste materials. This means they are not taken as a part of an extra procedure. For example only if you have scheduled bronchoscopy (a tube inserted to examine your airway) as part of your care will any excess fluid be taken during the procedure. Urine is collected only if a Foley catheter to help drain the bladder is already in place. Exhaled breath condensate is received only from patients with breathing tubes; this will not affect the machine’s function. None of these means of collection create an increased risk for the patient.
The blood draw is the same as any routine blood work that the nurses draw each day. Most patients in the ICU have a catheter inserted into a vein or artery so blood collection usually does not require any additional needle stick. If it is necessary to draw a venous blood sample [i.e. the person does not have a line we can draw from] then there is the risk of possible bruising at the needle site. We make every attempt to coordinate blood for the study with other routine blood draws so there is no needle stick for the purposes of this study only.
The other risk is that of the loss of privacy, since we will be reviewing the medical chart and we will be looking at genetic information. To protect patients, we assign a unique study number to all samples and all tests and analysis are done through that number. At the end of the study any links that could connect you to the blood such as a medical record number or a birth date will be erased so that no one, even the study investigators, will be able to identify any individual blood sample. We also put nothing in the chart, so that anyone who may be looking through your records like another doctor or insurance company will have no knowledge of your participation in this study.
6. Will we get individual results?
Per institutional guidelines, we cannot give individual analysis to patients. The purpose of this research is to generate scientific data that may help determine treatment options in the future. In addition, we erase identifying information at the end of the study so that no one can link a blood sample to a name. All private health information is kept in a locked secure place and only our trained study staff has access to it.
7. What about insurance getting to know genetic information? How is my privacy maintained?
There are two copies of the consent form – one for you and one for our study records. We do not put a copy in the medical record specifically to address this concern. There is no record of your participation in your medical chart. As mentioned above, study records are coded for privacy and kept in secure areas accessible only by trained staff.