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.

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.