ThoraSite: A device to improve accuracy of lateral decompression needle and chest tube placement.

BACKGROUND: Multiple reports have detailed an unacceptably high error rate in the siting of decompression needles and tubes and describe associated iatrogenic injuries. The objective of the current study was to measure the accuracy of the novel ThoraSite template for identifying an acceptable intercostal space (ICS) for lateral needle or tube thoracostomy. METHODS: Two trained operators used the ThoraSite to place radiopaque needles in the left and right lateral chests of 12 cadavers. An independent radiologist reviewed fluoroscopy images to determine the primary outcome: the ICS in which each needle was placed. Secondary outcomes were ICS's palpable through ThoraSite's Safe Zone; needle placement relative to the anterior axillary line (AAL) and midaxillary line (MAL); and percent correct placement (defined as the third, fourth, or fifth ICS from 1 cm anterior to the AAL to 1 cm posterior to the MAL). RESULTS: The six female and six male cadavers spanned 4 ft and 11 inches (150 cm) to 6 ft and 7 inches (201 cm), 80 lb (36 kg) to 350 lb (159 kg), and 16 kg/m to 42 kg/m body mass index. All 24 needles were placed in either the third (4 [17%] of 24 needles), fourth (10 [42%] of 24 needles), or fifth ICS (10 [42%] of 24 needles). In 10 (42%) of 24 assessments, two ICSs were palpable in ThoraSite's Safe Zone. All palpable ICSs were either the third (8 [24%] of 34), fourth (15 [44%] of 34); or fifth ICS (11 [32%] of 34). Twenty-three (96%) of 24 needles were inserted from 1 cm anterior to the AAL to 1 cm posterior to the MAL. Twenty-three (96%) of 24 needle placements were correct. CONCLUSION: ThoraSite use was associated with needle placement in the third, fourth, or fifth ICS in an area roughly spanning the AAL to MAL in anatomically diverse cadavers. By facilitating appropriate needle/tube placement, ThoraSite use may decrease iatrogenic injuries. Future study involving representative users may be useful to further evaluate ThoraSite accuracy. LEVEL OF EVIDENCE: Therapeutic and care management, level IV.

Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community.

STUDY OBJECTIVES: The US Food and Drug Administration (FDA) and Department of Health and Human Services created a method for obtaining a waiver of informed consent to permit research in emergency settings when patients are not competent. One of the requirements to obtain a waiver is public disclosure about the research. We describe approaches used to meet the public disclosure requirement. METHODS: We performed a qualitative content analysis of the FDA's repository for mandatory documentation of public disclosure efforts as of November 1999. Data from 4 studies were analyzed: 2 multi-institutional trials involving trauma and 2 smaller trials involving cardiac arrest. These efforts included both 1-way communications, such as announcements, and 2-way communications, such as focus groups and public meetings. Participation in and common concerns expressed during 2-way communications were noted, as was evidence of mechanisms of advance refusal and the collection of quantitative data on public opinion. RESULTS: One-way communications were the predominant method of disclosure. Many 2-way communications were not directed toward lay persons. Those that were often involved fewer than 15 participants. Concerns regarding inability to refuse study participation, racial biases affecting study design and execution, and ambiguity with regard to how community input would be used in study decision making were raised in several 2-way communications. A minority of participating hospitals announced mechanisms of advance refusal or collected quantitative data on public opinion concerning proposed research. CONCLUSION: Initial experience with obtaining a waiver of informed consent for emergency research suggests that community involvement and specific public concerns should be carefully considered in future applications for such a waiver.