The HCMC Department of Emergency Medicine will be conducting a medical research study starting in Fall 2011. The purpose of this press release is to educate and notify the public of the study. This study is different than most other research studies because it involves a process called exception from informed consent.
Direct laryngoscopy versus C-MAC device
This study is comparing the use of direct laryngoscopy to the C-MAC device for inserting a breathing tube in the emergency department.
The process of inserting a breathing tube in order to breathe for a person is called endotracheal intubation. It is done in the emergency department at HCMC about 30 times a week. In the emergency department intubation is done because something happened to the person that has made it hard to breathe, and it has to be done to keep them breathing. The process of endotracheal intubation is fast and usually only takes a few minutes.
The usual approach to endotracheal intubation is to use a device called a laryngoscope that fits in the mouth and holds it open while the tube is placed in the throat between the vocal cords. Sometimes this can be difficult, and so a device called a C-MAC is used, which is a laryngoscope with a video camera on the end that makes it easier to see the vocal cords. The purpose of the study is to find out if using the C-MAC device works better than the direct laryngoscope in patients who were going to be intubated using the laryngoscope.
Both of these devices are commonly used now, but the C-MAC is used if it appears that intubation process will be difficult. This study will help us to understand if we should be using the C-MAC device all the time or should continue to only use it when it looks like it’s going to be difficult to perform the intubation.
This study will start in the fall of 2011 in the HCMC Emergency Department. The HCMC Institutional Review Board (IRB) has approved the Community Consultation Plan for the direct laryngoscopy versus CMAC study.
Identifying patients who are eligible for the study
When an adult who requires endotracheal intubation is brought to the emergency department, all standard medical care will be given. In addition, the emergency doctor will screen the patient to see if he or she is eligible for the research study.
Adults (18 years and older) who require endotracheal intubation are eligible for the study if their doctor is planning on intubating them with a direct laryngoscope.
Study protocol and procedures
The doctor will intubate the patient. Half of the patients will be intubated with the direct laryngoscope and the other half will be intubated with the C-MAC. If the intubation isn’t done successfully on the first try, the physician will go back to using whatever device they feel is most appropriate to be successful. Patients are randomly assigned to receive either device, like flipping a coin.
The research team will collect information about how long it took to get the intubation completed successfully and if there were any problems. The patients chart will be checked after they leave the hospital to see how long they were in the intensive care unit (ICU) and if they had any problems with pneumonia.
Exception from informed consent
Patients who are having difficulty breathing on their own are very confused and disoriented. Because of their medical condition, they cannot make decisions about their care. If the physician determines the patient is eligible to be in the study, then the patient will be enrolled into the study.
When the patient is medically stable, a member of the research team will speak to the patient or their family member to inform them of the research study. They will be given written information and an opportunity to ask questions. At this time, they will also be asked if they will consent to continue to participate in the study.
How this is different from other research studies
All research studies are reviewed and approved by a panel of scientists and ethicists called the Institutional Review Board (IRB) before they can be performed.
Under normal circumstances, medical researchers are required to explain the research study and obtain consent from the patient before starting the study. However in some emergency situations, this cannot be done.
Endotracheal intubation must be performed quickly when a person can’t breathe on their own. The patient will likely be very confused and unable to consent to be in the study. There will not be enough time to talk a legal representative of the patient about the study. For this reason, a person who needs to be intubated will be enrolled in this study without obtaining written consent. This situation is called exception from informed consent. This study meets the guidelines for exception from informed consent as outlined by the federal government and the IRB.
Additional information about exception from informed consent
The federal government has developed some guidelines that allow researchers, in very special cases, to do research without first obtaining consent from the patient. Exception from informed consent applies only if:
- the person is in a life-threatening situation
- current treatments are unproven or unsatisfactory
- the study might directly benefit the person
- it is not possible to obtain consent from the patient because of the patient’ s medical condition or from the legal representative because of the limited time available to treat the medical condition.
Two articles have been written on the subject of “Exception from Informed Consent” by Dr. Michelle Biros, one of the emergency medicine doctors at HCMC.
- Research Without Consent: Current Status, 2003
- The Research on Community Consultation: An Annotated Bibliography
If someone does not want to be enrolled in this research study if he or she should be brought into the HCMC emergency department, they must contact Dr. Miner at 612-873-3131 or send an email to: firstname.lastname@example.org. Information will be mailed to the requestor along with an “OPT OUT” bracelet to wear to inform Emergency Department personnel that the patient does not want to be enrolled if intubation is required.
Full details can be obtained at (http://hcmced.org/studies.html) or by contacting us at 612-873-9528 or email@example.com.