Christopher R. Turner

Prevention of intraoperative awareness with explicit recall in an unselected surgical population: a randomized comparative effectiveness trial.

Background:Intraoperative awareness with explicit recall occurs in approximately 0.15% of all surgical cases. Efficacy trials based on the Bispectral Index® (BIS) monitor (Covidien, Boulder, CO) and anesthetic concentrations have focused on high-risk patients, but there are no effectiveness data applicable to an unselected surgical population. Methods:We conducted a randomized controlled trial of unselected surgical patients at three hospitals of a tertiary academic medical center. Surgical cases were randomized to alerting algorithms based on either BIS values or anesthetic concentrations. The primary outcome was the incidence of definite intraoperative awareness; prespecified secondary outcomes included postanesthetic recovery variables. Results:The study was terminated because of futility. At interim analysis the incidence of definite awareness was 0.12% (11/9,376) (95% CI: 0.07–0.21%) in the anesthetic concentration group and 0.08% (8/9,460) (95% CI: 0.04–0.16%) in the BIS group (P = 0.48). There was no significant difference between the two groups in terms of meeting criteria for recovery room discharge or incidence of nausea and vomiting. By post hoc secondary analysis, the BIS protocol was associated with a 4.7-fold reduction in definite or possible awareness events compared with a cohort receiving no intervention (P = 0.001; 95% CI: 1.7–13.1). Conclusion:This negative trial could not detect a difference in the incidence of definite awareness or recovery variables between monitoring protocols based on either BIS values or anesthetic concentration. By post hoc analysis, a protocol based on BIS monitoring reduced the incidence of definite or possible intraoperative awareness compared with routine care.

The Clinical and Technical Evaluation of a Remote Telementored Telesonography System During the Acute Resuscitation and Transfer of the Injured Patient

BACKGROUND Ultrasound (US) has an ever increasing scope in the evaluation of trauma, but relies greatly on operator experience. NASA has refined telesongraphy (TS) protocols for traumatic injury, especially in reference to mentoring inexperienced users. We hypothesized that such TS might benefit remote terrestrial caregivers. We thus explored using real-time US and video communication between a remote (Banff) and central (Calgary) site during acute trauma resuscitations. METHODS A existing internet link, allowing bidirectional videoconferencing and unidirectional US transmission was used between the Banff and Calgary ERs. Protocols to direct or observe an extended focused assessment with sonography for trauma (EFAST) were adapted from NASA algorithms. A call rota was established. Technical feasibility was ascertained through review of completed checklists. Involved personnel were interviewed with a semistructured interview. RESULTS In addition to three normal volunteers, 20 acute clinical examinations were completed. Technical challenges requiring solution included initiating US; audio and video communications; image freezing; and US transmission delays. FAST exams were completed in all cases and EFASTs in 14. The critical anatomic features of a diagnostic examination were identified in 98% of all FAST exams and a 100% of all EFASTs that were attempted. Enhancement of clinical care included confirmation of five cases of hemoperitoneum and two pneumothoraces (PTXs), as well as educational benefits. Remote personnel were appreciative of the remote direction particularly when instructions were given sequentially in simple, nontechnical language. CONCLUSIONS The remote real-time guidance or observation of an EFAST using TS appears feasible. Most technical problems were quickly overcome. Further evaluation of this approach and technology is warranted in more remote settings with less experienced personnel.

A retrospective study of intraoperative awareness with methodological implications.

BACKGROUND: Awareness during general anesthesia is a problem receiving increased attention from physicians and patients. Large multicentered studies have established an accepted incidence of awareness during general anesthesia as approximately 1–2 per 1000 cases or 0.15%. More recent retrospective data, however, suggest that the actual incidence may be as low as 0.0068%. METHODS: To assess the incidence of awareness at our institution, we conducted a review of adult patients undergoing surgical procedures over a 3-year period. Information on awareness came from entries of “Intraoperative Awareness” captured during our standard evaluations on postoperative day one in our perioperative information system. Patients were not questioned specifically about awareness. RESULTS: We reviewed 116,478 charts; 65,061 patients received general anesthesia and 51,417 received other types of anesthesia. Of the patients receiving general anesthesia, 44,006 had complete postoperative documentation. The reported incidence of undesired intraoperative awareness in this population was 10/44,006 (1/4401 or 0.023%). Of the patients who received other anesthetic modalities, 22,885 had complete postoperative documentation. Undesired intraoperative awareness was reported in 7/22,885 patients who did not receive general anesthesia (1/3269 or 0.03%). The reported incidence of intraoperative awareness was not statistically different between the two groups (P = 0.54). Relative risk of intraoperative awareness during a general anesthetic compared with a nongeneral anesthetic was 0.74, with 95% confidence interval [0.28, 2.0]. CONCLUSION: Using a retrospective methodology, reports of intraoperative awareness are not statistically different in patients who received general anesthesia compared with those who did not. These results suggest that, despite success with other rare perioperative events, the resolution of retrospective database analyses may be too low to study intraoperative awareness.

Assessment of intraoperative awareness with explicit recall: a comparison of 2 methods.

BACKGROUND:Superiority of the modified Brice interview over quality assurance techniques in detecting intraoperative awareness with explicit recall has not been demonstrated definitively. METHODS:We studied a single patient cohort to compare the detection of definite awareness using a single modified Brice interview (postoperative day 28–30) versus quality assurance data (postoperative day 1). RESULTS:The incidence of awareness based on the modified Brice interview was 19 per 18,847 or 0.1%. Fewer awareness cases (incidence 0.02%) were detected by the quality assurance approach (P < 0.0001). CONCLUSION:The modified Brice interview is the preferred modality for assessing intraoperative awareness with explicit recall.

User's perceptions of remote trauma telesonography

We established a pilot tele-ultrasound system between a rural referring hospital and a tertiary care trauma centre to facilitate telementoring during acute trauma resuscitations. Over a 12-month period, 23 tele-ultrasound examinations were completed. The clinical protocol examined both the Focused Assessment with Sonography for Trauma (FAST) and the Extended FAST (EFAST) for pneumothoraxes. Twenty of the examinations were conducted during acute trauma resuscitations and three during live patient simulations. FAST examinations were completed in all 23 cases and EFAST examinations in 17 cases. There were 18 clinical users, of whom 14 completed a survey (76% response rate). Overall, 93% of respondents were either satisfied or very satisfied with the telemedicine interaction and agreed or strongly agreed that the technology could potentially benefit injured patients in the far north of Canada. In addition, 93% of the respondents felt that the project had improved collegiality between the two institutions involved. The majority of respondents (71%) agreed or strongly agreed that the project had improved their ultrasound skills. We believe that as further experience is obtained, tele-ultrasound will prove to be an important aid to the care of remotely injured and ill patients.

Prospective evaluation of a guideline for the selective elimination of pre-reduction radiographs in clinically obvious anterior shoulder dislocation

OBJECTIVE Research has demonstrated that experienced emergency physicians can identify a subgroup of patients with shoulder dislocation for whom pre-reduction radiographs do not alter patient management. Based on that research, a treatment guideline for the selective elimination of pre-reduction radiographs in clinically evident cases of anterior shoulder dislocation was developed and implemented. The primary objective of this study was to prospectively determine whether the treatment guideline safely eliminates unnecessary radiographs. METHODS We enrolled a convenience sample of patients who presented to our rural emergency department with possible shoulder dislocation between November 2000 and April 2001. Physicians scored their level of clinical diagnostic certainty on a 10-cm visual analogue scale prior to viewing pre-reduction radiographs (if obtained). Data were collected on clinical scoring and evaluation, compliance with the guideline, and outcomes. RESULTS A total of 63 patients were enrolled, ranging in age from 17 to 79 years (mean = 33); 87.3% were male. Emergency physicians were certain of shoulder dislocation in 59 (93.7%) patients (95% CI, 84.5%-98.2%) and complied with the treatment guideline in 52 patients (82.5%). Most deviations from the treatment guideline involved the elimination of post-reduction radiographs (which the guideline recommends for all patients). The treatment guideline eliminated 56 (88.9%, 95% CI, 78.4%-95.4%) pre-reduction radiographs, as compared to the standard practice of obtaining pre-reduction films for all cases of suspected shoulder dislocation (p < 0.0001) CONCLUSIONS Experienced emergency physicians are frequently certain of the diagnosis of anterior shoulder dislocation on clinical grounds alone and can comfortably and safely use this guideline for the selective elimination of pre-reduction radiographs. Compliance with the guideline substantially decreases pre-reduction radiographs. Validation of the guideline in other settings is warranted.

Comparison of the glidescope, CMAC, storz DCI with the Macintosh laryngoscope during simulated difficult laryngoscopy: a manikin study

BackgroundVideolaryngoscopy presents a new approach for the management of the difficult and rescue airway. There is little available evidence to compare the performance features of these devices in true difficult laryngoscopy.MethodsA prospective randomized crossover study was performed comparing the performance features of the Macintosh Laryngoscope, Glidescope, Storz CMAC and Storz DCI videolaryngoscope. Thirty anesthesia providers attempted intubation with each of the 4 laryngoscopes in a high fidelity difficult laryngoscopy manikin. The time to successful intubation (TTSI) was recorded for each device, along with failure rate, and the best view of the glottis obtained.ResultsUse of the Glidescope, CMAC and Storz videolaryngoscopes improved the view of the glottis compared with use of the Macintosh blade (GEE, p = 0.000, p = 0.002, p = 0.000 respectively). Use of the CMAC resulted in an improved view compared with use of the Storz VL (Fishers, p = 0.05). Use of the Glidescope or Storz videolaryngoscope blade resulted in a longer TTSI compared with either the Macintosh (GLM, p = 0.000, p = 0.029 respectively) or CMAC blades (GLM, p = 0.000, p = 0.033 respectively).ConclusionsUnsurprisingly, when used in a simulated difficult laryngoscopy, all the videolaryngoscopes resulted in a better view of the glottis than the Macintosh blade. However, interestingly the CMAC was found to provide a better laryngoscopic view that the Storz DCI Videolaryngoscope. Additionally, use of either the Glidescope or Storz DCI Videolaryngoscope resulted in a prolonged time to successful intubation compared with use of the CMAC or Macintosh blade. The use of the CMAC during manikin simulated difficult laryngoscopy combined the efficacy of attainment of laryngoscopic view with the expediency of successful intubation. Use of the Macintosh blade combined expedience with success, despite a limited laryngoscopic view. The limitations of a manikin model of difficult laryngoscopy limits the conclusions for extrapolation into clinical practice.

Product Placement of Medical Products

Abstract Product placement is a well-established marketing technique that nevertheless continues to provoke considerable criticism and debate. Likewise, direct-to-patient marketing of pharmaceuticals is legally acceptable but is controversial among ethicists and medical professionals. Little has been published regarding the ethical challenges and pitfalls involved in medical marketing, including the issues of whether medical products should be treated differently from consumer products and whether pharmaceuticals are distinct from medical devices. Discussed are examples of pharmaceutical marketing as well as an episode from the Chicago Hope television program in which a medical device was touted as a solution for a problem for which the Food and Drug Administration (FDA) has not approved the use of the device. Legal and ethical considerations for product placement of medical products as they influence patient demand are also analyzed, as well as some of the pitfalls that may accompany direct marketing of medical products.

Focused abdominal ultrasound for blunt trauma in an emergency department without advanced imaging or on-site surgical capability

OBJECTIVES To determine whether focused abdominal sonogram for trauma (FAST) in a rural hospital provides information that prompts immediate transfer to a tertiary care facility for patients with blunt abdominal trauma who would otherwise be discharged or held for observation. METHODS Prior to the study, participating emergency physicians underwent a minimum of 30 hours of ultrasound training. All patients who presented with blunt abdominal trauma to our rural hospital between Mar. 1, 2002, and Apr. 30, 2003, were eligible for study. Following a history and physical examination, the emergency physician documented his or her disposition decision. A FAST was then performed, and the disposition reconsidered in light of the FAST results. RESULTS Sixty-seven FAST exams were performed on 65 patients. Three examinations (4.5%) were true-positive (95% confidence interval [CI] 0.9%-12.5%); 60 (89.6%) were true-negative (95% CI 79.7%-95.7%), 4 (6%) were false-negative (95% CI 1.7%-14.6%) and none (0%) were false-positive (95% CI 0%-5.4%). These values reflect sensitivity, specificity, negative predictive value and positive predictive values of 43%, 100%, 94% and 100% respectively. FAST results did not alter the decision to transfer any patient (0%: 95% CI 0.0%-5.4%), although one positive FAST may have led to an expedited transfer. One of 38 patients who was discharged after a negative FAST study returned 24 hours later because of worsening symptoms, and was ultimately found to have splenic and pancreatic injuries. CONCLUSIONS This study failed to demonstrate that FAST improves disposition decisions for patients with blunt abdominal trauma who are evaluated in a hospital without advanced imaging or on-site surgical capability. However, the study is not sufficiently powered to rule out a role for FAST in these circumstances, and our data suggest that up to 5.4% of transfer decisions could be influenced by FAST. Rural emergency physicians should not allow a negative FAST study to override a clinical indication for transfer to a trauma centre; however, positive FAST studies can be used to accelerate transfer for definitive treatment.

Prospective evaluation of clinical assessment in the diagnosis and treatment of clavicle fracture: Are radiographs really necessary?

INTRODUCTION Current recommended treatment for middle-third clavicle fractures is limited to the use of ice, analgesics, a sling, and rest. Radiography for these fractures would be superfluous if physicians could accurately identify them by clinical examination alone. The primary purpose of this study was to determine whether emergency physicians can accurately diagnose clavicle fractures, and whether they can differentiate middle-third fractures from medial- or lateral-third fractures by clinical assessment alone. METHODS We enrolled a convenience sample of patients who presented to our rural emergency department with possible clavicle fracture between Nov. 1, 2001, and Apr. 30, 2002. Prior to viewing radiographs, physicians scored their clinical certainty of diagnosis on a 10-cm visual analogue scale. When certain of fracture, physicians determined the location of the fracture, the nature of the fracture and their hypothetical comfort in treating the injury without radiography. RESULTS In 51 of 77 enrolled patients (66%; 95% confidence interval [CI], 54.6%-76.6%), treating physicians were certain of the diagnosis of clavicle fracture prior to radiography. In these 51 cases, radiography revealed a fracture in 50 cases (98.0%; 95%CI, 89.6%-99.9%). The physicians were 100% accurate for 4 fractures clinically identified as lateral-third fractures (95% CI, 39.7%-100%) and for 41 fractures identified as middle-third fractures (95% CI, 91.4%-100%). They were correct on only 1 of 5 injuries (20%; 95% CI: 1%-72%) they clinically identified as medial-third fractures. Despite high clinical accuracy with middle-third fractures, they stated in 27 of 42 cases (64%; 95%CI, 48.0%-78.5%) that they would have been uncomfortable treating the patient without a radiograph. CONCLUSIONS This study provides evidence that experienced emergency physicians are highly accurate when they are clinically certain of clavicle fracture. Further, when emergency physicians do clinically diagnose clavicle fracture, they can accurately identify the patient subgroup that will be responsive to conservative treatment. Routine radiography of obvious middle-third clavicle fractures does not appear to improve diagnostic accuracy or treatment decisions.