Informed Consent for Research

[VentMedic]

I had placed this link under the Hypothermia thread but thought it would be interesting as a topic by itself especially with new meds and equipment being introduced. This gives you an idea of how EMS research is allowed and practiced.

http://www.uwmedicine.org/NR/rdonly...O_Continued_Participation_Consent_9_22_06.pdf

INDUCED HYPOTHERMIA USING COLD IV FLUID IN CARDIAC ARREST

PURPOSE OF THE STUDY
You recently experienced a cardiac arrest and were resuscitated by the Seattle Fire Department or King
County Emergency Medical Services. During that time you were enrolled in the “Induced Hypothermia Using
Cold IV Fluid in Cardiac Arrest” study. Federal regulations usually do not allow patients to be enrolled in a
study without their informed consent or without the consent of their legally authorized representative.
However, in certain limited situations, such as emergency medicine research, the U.S. Food and Drug
Administration (FDA) does allow some studies to be conducted without prior consent.

Following cardiac arrest, the brain is often injured due to a lack of blood and oxygen. Some patients will
recover and wake up. However, a majority of patients will never wake up. Based on studies on animals and
on patients who are admitted to the hospital following cardiac arrest, induced hypothermia (cooling the body)
has been shown to improve the chances that a patient will wake up. One method to decrease the body’s
temperature is to give cold fluid into the veins through an I.V. (small needle in the vein). This method of
cooling has been tested in cardiac arrest patients admitted to the hospital and has been proven to be
beneficial and safe. However, this method has not been tested on patients outside the hospital.

BENEFITS OF THE STUDY
You may not directly benefit from this study. This study may benefit future patients with cardiac arrest.

Subject’s Statement
The study described above has been explained to me. I have had the opportunity to ask questions. I am free to withdraw from the study at any time without penalty or loss of benefits. If I have questions about the research I may contact one of the Investigators listed on the first page. If I have questions about my rights as a research subject, I can call the Human Subjects Division at (xxx) xxx-xxxx. I will receive a copy of this consent form.

 

[Ridryder911]

I wonder how many have sued for this? The same as in the Polyheme study, not having informed consent prior to before administration; even though there would be no way of possibly obtaining it.

R/r911

 

[BossyCow]

So, how is informed consent obtained from someone in full arrest? "We'll assume you wish to participate unless you tell us different."

 

[Flight-LP]

Implied consent comes to mind...................

Why anyone would pitch a :censored::censored::censored::censored::censored: about something that has been proven to be beneficial for almost 50 years is beyond me.

Do what best benefits your patient, I really do not see this becoming as much of an issue as the Polyheme study. But with the stupidity of society, hey who knows.......................

 

[VentMedic]

Why anyone would pitch a :censored::censored::censored::censored::censored: about something that has been proven to be beneficial for almost 50 years is beyond me.

...................

How many years has your service used hypothermia protocol for cardiac arrest in the field?

Are all your ground paramedics in your area able to do paralytics?

What has been the outcome? What age group? What equipment?

 

[Flight-LP]

How many years has your service used hypothermia protocol for cardiac arrest in the field?

Are all your ground paramedics in your area able to do paralytics?

What has been the outcome? What age group? What equipment?

We have been doing induced hypothermia for about a year now. Our overall survivability (i.e. discharged neurologically intact) from all arrests, not just those meeting Utstein criteria, is currently just under 20%. We use the protocol in all non-gravida pts. over 16 years of age that we obtain ROSC on.

All of our Paramedics have standing orders for both Norcuron and Versed to implement this protocol and we use regular cooled NS along with Dopamine.

Utilizing this along with the implementation of the ITD and direct cath lab access has enabled us to offer a level of cardiac care that few agencies can offer. We have a few more modalities that we are currently reviewing that will put us even further ahead. More to come...................

 

[VentMedic]

We have been doing induced hypothermia for about a year now. ..................

Utilizing this along with the implementation of the ITD and direct cath lab access has enabled us to offer a level of cardiac care that few agencies can offer. We have a few more modalities that we are currently reviewing that will put us even further ahead. More to come

You have to thank the EMS agencies, hospitals and physicians willing to back this research as well as summit all the necessary paperwork for your ability to do this .

If you do a literature search on the studies from just the 1980s you will see why hypothermia did not become popular.

Your survival rate is exceptional since the norm is 1% - 20% in the studies. Of course if you only did 5 patients and 1 survived that would be 20%.

This is a study from Houston which describes the problems encountered while "researching" the best method for cooling. Even with patients being hand picked, the success is not always predictable.

http://circ.ahajournals.org/cgi/content/full/104/15/1799

You can also see by the other studies in the references throughout the years why hypothermia has not been rapid to catch on especially in EMS. It has taken a lot of research and still no best way has clearly been defined.

I could also make the same statement about CPAP which has been around and proven successful for more than 50 years that you did earlier. However, knowing how CPAP functions in the hospital and how many trials had to be done to get something designed that was portable enough for an ambulance took time. Then it had to go through the standard trials for approval with the The Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP). This process can take 5 or more years.

Any new device or modality doesn't just appear out of nowhere. That is why there are thousands of journals with thousands of research articles. Even with the tried and true, there is still more research that can be done to improve the odds or perfect the system to make it available to the masses.

 

[Flight-LP]

I am very familiar with the 1998 trial performed at Methodist Hospital. You are correct that there were many complications, but the biggest was time. Time wasted in attempting to obtain consent. Something that we currently do not deal with. The treatment is initiated, period. Time is also saved due to active warming vs. the passive methods attempted in this study. As far as the compications go contributing to the 5 deaths, none were directly caused by the hypothermia. Aspiration pneumonia and transient hypoxia were both caused by the management (or mis-management I suppose) of the airway. We have performed I believe around 30 hypothermia inductions. I do not have current stats from the last quarter, but again we are averaging around 20%.

I agree we have come far, but still have far to go. We may never find the "best way", but I can attest first hand that our current tools are saving more lives. Eventually, my words and the actions of my agency will be printed in yet another study of the "latest and greatest". Some will acknowledge, others will dismiss as has always been the way in research. But in the meantime, I sleep better at night knowing that I AM making a positive difference in someones life. It also makes me proud to know that in this career of stagnation, bickering, and non-acknowledgement of professional status, that I belong to an agency that is stepping forward and making advancing strides in our industry. It is my sincerest hope that more will follow.............

 

[VentMedic]

there were many complications, but the biggest was time. Time wasted in attempting to obtain consent. Something that we currently do not deal with. The treatment is initiated, period.

What I am saying, in order for you to now be able to do this, someone had to lay the ground work to make this an acceptable protocol for you to now implement. Your agency is not the first and hopefully won't be the last.

 

[Flight-LP]

And I am very greatful for the efforts of the others exhibiting similar interests in advancing the care available to our patients........................