ATLANTA – The American Society of Anesthesiologists (ASA; Park Ridge, Illinois) has adopted an advisory statement focused on the issue of surgical awareness at its annual meeting here this week, with a vote that is unlikely to quiet continuing debate concerning the precise value of brain-function monitoring to address the problem.

The organization’s House of Delegates voted to accept, with minor changes, the draft version of the advisory that it issued this summer. The advisory encourages closer adherence to current practice protocols for delivery of anesthesia, but it maintains wording indicating that brain-function monitors, while offering another assessment tool, fail to provide a breakthrough advance over other methods for assessing the depth of anesthesia.

The advisory also clearly states that brain-function monitors have not yet been shown as being more effective than other systems in assessing surgical awareness – a condition in which the surgical patient is awake and aware but unable to respond – but may be helpful on a case-by-case basis.

The advisory thus serves to leave the technology in a sort of twilight zone in terms of validation and efficacy.

Adoption of the advisory appears in some measure to deliver a blow to Aspect Medical Systems (Newton, Massachusetts), which has long touted the ability of its Bispectral Index (BIS) monitoring system to measure depth of anesthesia and to identify surgical awareness in patients.

On the other hand, the focus by the ASA on the issue at this year’s meeting – during the 100th anniversary of the organization – serves to give it much higher profile both in the clinical suite and among patients.

And on a clearly positive side, it is likely to help push broader clinical trials to assess the technology.

Importantly, the advisory is the very first that the ASA has issued on the topic of surgical awareness, a problem with a growing profile in the public mind as the result of patient lawsuits, some of them rather high-profile.

The need for improved monitoring to prevent surgical awareness also has been called for by the Joint Commission on the Accreditation of Healthcare Organizations (Oakbrook Terrace, Illinois).

During a Tuesday afternoon press conference, Orin Guidry, MD, the ASA’s new president, emphasized the use of brain-function monitors as an “adjunct” to all the other measuring technologies and protocols available to the anesthesiologist and that they might be most useful for some types of patients.

Those cases, he said, in response to questions, might include older patients unable to withstand heavy doses of anesthesia, trauma patients and women undergoing emergency C-section.

Overall, Guidry said that informing patients concerning the possibility of surgical awareness and the use of monitors might make them more comfortable going into surgery.

In response to a question from Diagnostics & Imaging Week as to whether brain-function monitoring should be part of the anesthesiologist’s regular armamentarium of assessment tools, he said: “Going forward, in hospitals that handle cases in which there may be an increased risk of patients who might experience awareness ... they’re going to have to have the availability of these devices.”

As to whether a brain monitor should be available in every OR suite, he said: “That’s a decision each institution is going to have to answer on their own.”

Perhaps Guidry’s most intriguing comment was that a true evaluation of brain-function monitoring would require a clinical trial of 750,000 patients, given the infrequency of its occurrence.

He said that the ASA was interested in seeing this type of study, but that the organization did not have the resources to pursue it on its own. The organization’s foundation might consider the “feasibility” of such a trial, he said, and “may go to the point of issuing a request for such a proposal. We would like to support someone else studying this question.”

While the ASA did not place a broad stamp of approval on brain-function monitoring technology, Aspect issued a statement on Tuesday giving a largely positive read to the organization’s vote on the advisory.

One paragraph of the statement quoted Nassib Chamoun, company president and CEO:

“The ASA approval of this document represents a significant step forward in addressing intraoperative [surgical] awareness and the role of brain function monitoring and reinforces the society’s leadership in advancing patient safety. We believe that the guidance provided by the ASA, combined with the Sentinel Event Alert issued to healthcare facilities by the Joint Commission on Accreditation of Healthcare Organizations, supports the need for healthcare facilities to make brain monitoring available in every operating room that serves patients at risk for awareness.”

The rather tenuous status of brain-function monitoring in the minds of practicing anesthesiologists was highlighted earlier at the ASA meeting during a Sunday “point/counterpoint” debate on the issue, with conference attendees referring to false readings by BIS technology and its ability to identify but not prevent surgical awareness.

The discussion implicitly acknowledged the occurrence of surgical awareness, and the ASA has stated that it is thought to occur, on average, once or twice for every 1,000 procedures. But it also continues to raise questions concerning the exact frequency of the phenomenon and how to define it.

An attendee at the point/counterpoint session was Carol Weihrer, who said that she has been in contact with at least 2,600 victims of surgical awareness.

“I speak for many, many victims from all over the world,” Weihrer said, and she has established a web site that highlights this problem and encourages reporting by others who have experienced it.