|
 n
support of Board of Directors action in August 2005,
the House of Delegates approved a restricted grant
of up to $500,000 to conduct studies on cerebral function
monitoring. Subsequently, ASA requested that the ASA
Committee on Research and the Foundation for Anesthesia
Education and Research (FAER) work together and, after
concluding a satisfactory feasibility study, develop
and distribute to qualified researchers a request
for proposals to conduct a randomized, controlled
trial that involves a sufficient number of patients
to prove or disprove to a reasonable degree of scientific
probability whether brain function monitoring reduces
the incidence of intraoperative awareness under general
anesthesia.
The incidence of awareness is rare in the general
population but is enhanced in specific subgroups of
patients. For example patients undergoing cesarean
section or high-risk cardiac surgery are at a much
higher risk of awareness, as demonstrated in the B-AWARE
trial.1
FAER is requesting proposals for a project to evaluate
the effectiveness of brain function monitoring in
reducing the incidence of intraoperative awareness.
The proposal requests a randomized, controlled design,
but alternative study designs will be considered.
The outcomes of interest should be specified, and
relevancy of these outcomes to the patient should
be considered. Power calculations for either a feasibility
or outcome study should be reported.
Proposals will be judged on their generalizability
to the entire population of patients undergoing general
anesthesia and will be evaluated and scored through
the same process as other FAER grant applications.
Both feasibility and costs of the trial will be critical
to the funding decision. In the case of a proposed
feasibility study, a rough estimate of the cost of
the ultimate outcome study should be included. If
the costs are prohibitive, or no studies are deemed
feasible, then no grant may be awarded.
Proposals must be submitted to FAER by August
15, 2007. Information regarding FAER grants
and application materials is available at faer.org/grants.php.
Questions pertaining specifically to this request
for proposal may be directed to the FAER office (507)
266-6866. Please contact Jeffrey L. Apfelbaum, M.D.,
at jeffa@dacc.uchicago.edu
for information relative to the ASA position on this
subject.
Reference:
1. Myles PS, Leslie K. Bispectral index monitoring
to prevent awareness during anaesthesia: The B-Aware
Randomised Controlled Trial. Lancet. 2004;
363:1757-1763.
return to top |