The Hennepin County Medical Center (HCMC) Department of Emergency Medicine will be conducting a medical research study starting in Fall 2014. 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.
Endotracheal intubation is when a tube is placed in a person’s throat in order to help them breathe. It is most frequently done when a person is having an operation, but in the Emergency Department it is done because something happened to the person that has made it hard for them to breathe. The process of endotracheal intubation is fast and usually only takes a few minutes. It is done in the Emergency Department at HCMC about 30 times a week. Before doctors intubate a patient, medication is given to make the patient sleepy and relaxed so that they are comfortable during the procedure.
Sometimes, when the medications are wearing off and the patient is waking up, the patient will accidentally pull the breathing tube out. Accidentally removing the tube before the patient can breathe easily can cause more difficulty breathing, or other medical problems. In these cases the tube will need to be replaced immediately.
Researchers at HCMC are working on a way to prevent this by helping to test the new design of breathing tubes that are harder to accidentally pull out.
This study will start in the fall of 2014 and will be done in the Emergency Department at HCMC. The Human Subjects Research Committee, the Institutional Review Board (IRB) at HCMC, has approved the Community Consultation Plan for this study. The full title of this study is A randomized comparative multicenter, open label, non-inferiority study, to compare the SolidAIRity® Airway Stabilization System’s ability to prevent unplanned extubation relative to standard of care in critically ill or injured patients requiring Emergency Department (ED) or Intensive Care Unit (ICU) oral intubation for airway management and admission to the ICU.
Purpose: This study will randomly assign (like flipping a coin) patients who are going to be intubated to receive either the standard breathing tube or the breathing tube with the new design. This study will help us to understand if one of these tubes is better for keeping patients from removing a tube from their airway.
IDENTIFYING ELIGIBLE PATIENTS
When an adult (a patient 18 years of age or older) who requires endotracheal intubation is brought to the HCMC Emergency Department, standard medical care will be given. In addition, the Emergency Department physician will check the patient to see if he or she is eligible for this research study. People who are not suited for intubation will be excluded.
If the physician decides that the patient is eligible for this research study, the patient will receive either the standard breathing tube or the breathing tube with the new design. Half of the patients in the study will receive one tube and half will receive the other tube for intubation. All other medical care will be given at the discretion of the treating physician.
The research team will collect information about the patient’s vital signs, demographics and medications, how long it took to complete the intubation, and whether there were any problems during the intubation. Intubations will also be recorded on video. While still intubated in the ICU, the patient will be provided with regular oral care as is standard of care, and the extubation will be recorded on video, if possible.
There are risks and benefits to every study. The risk of this new breathing tube includes possible skin, mouth, or dental injury as compared to the regular breathing tube. The potential benefit of the new breathing tube would be patients are less likely to pull out the breathing tube on their own as compared to the regular breathing tube.
EXCEPTION FROM INFORMED CONSENT
Under normal circumstances, medical researchers are required to explain a research study and to obtain consent from a patient before starting a study. In some emergency situations, this cannot be done.
When a patient cannot breathe on their own, endotracheal intubation must be performed quickly. The patient will be unable to breathe or make decisions about their medical care. There will not be enough time to talk to a family member of the patient about the study before it can be done. For this reason, a patient who needs to be intubated will be enrolled in this study without obtaining written consent. If the physician determines the patient is eligible to be in this study, then the patient will be enrolled.
Once the patient is medically stable, a member of the research team will speak to the patient or one of their family members to inform them of the research study. They will be given written information about the study and an opportunity to ask questions. At this time, they will also be asked if they will consent to continue to participate or have their family member continue to participate in the study.
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.
OPTING OUT OF THE STUDY
If you do not want to be enrolled in this research study in the case that you are brought into the HCMC Emergency Department, you must contact Dr. James Miner at James.Miner@hcmed.org or Dr. Johanna Moore at Johanna.Moore@hcmed.org or (612) 873-9366. A bracelet with the words “SolidAIRity Airway Study Declined” will be mailed to you to wear in order to inform Emergency Department personnel that you do not want to be enrolled in this study if intubation is required.
Details of the study can be obtained online at http://www.clinicaltrials.gov or by contacting one of the study physicians.