Frequently Asked Questions

ICP RCT Trial 2007 - 2013

Study summary. This Randomized Control Trial (“study”) examined the impact on outcome of two different treatment protocols. One was directed in response to monitored ICP values and designed in accordance with the U.S. Guidelines for the Management of Severe Traumatic Brain Injury in Adults. In the other, treatment of intracranial pressure was guided by the results of serial CT imaging and the clinical examination of the patient (neurologic exam and pupillary status) and was based on an ad hoc protocol that represented an amalgamation of the treatment methods ongoing at our three original study centers. Patients were randomly assigned to one of these two groups and outcomes were examined over six months.

What are the most important results from the study and how should I present them to my colleagues?

Was there any suggestion that the ICP monitoring treatment was better?

Do I need to use ICP monitoring?

What questions does this study answer?

  1. It tells us that the two protocols, applied to all patients meeting the study criteria, should produce similar outcomes under similar conditions.
  2. It tells us that, under the study conditions, a protocol based on monitored ICP was associated with fewer treatments and a shorter treatment-duration aimed at intracranial hypertension while producing an outcome similar to the non-monitor-based protocol.

Is it wrong to use the PIC if it is no better than the standard treatment?

If the PIC oriented treatment shows the outcomes are no better than the ICE arm, should I sell our equipment to be able to purchase other more needed equipment?

Should I insist that our hospital use the ICE protocol as it produced results as good as that with PIC?

How was the protocol for managing patients with ICP monitoring developed?

How was the ICE protocol developed?

Are there alternative protocols for non-monitored patients?

Can I modify the protocols (e.g. use hypertonic saline instead of mannitol as first choice)?

With all the data we collected, are there not other questions which could be answered from the data base?

Why bother to conduct another non PIC study if the current treatment works as well as the PIC monitored treatment?

Why must these kinds of studies be done in developing countries? Are we taking advantage of people in low- and middle-income countries?

Why was this study done in these Latin American Countries?

How might we start our own studies?

Would there be support from ALAS or the University of Washington or other institutions for research projects?