Feasibility of acute clinical trials during aerial interhospital transfer.

BACKGROUND AND
PURPOSE: In rural America, patients are often first seen at a small community hospital and then transferred to a tertiary care center by helicopter for further care. If acute clinical research were feasible during the aerial interhospital transport, more patients might be enrolled in trials at a critical earlier stage.
METHODS: Prospective data were collected for all aerial transfers of a university-based helicopter service from April 2005 to January 2006. Flight nurses were educated about stroke research and offered certification and participation. Data collected included patient characteristics and the availability of relatives to provide surrogate consent.
RESULTS: All 12 flight nurses completed the institutional review board certification requirements and collected data on 215 transfers. Sixty-one patients had acute stroke or myocardial events (MIs). The median time from symptom onset to helicopter arrival at an outside hospital was 213 minutes (range, 90 to 2135) for ischemic stroke (n=12), 186 (45 to 1332) for intracranial hemorrhage (n=28), and 157 (47 to 1044) for MI (n=21). A relative was available in >74% of those transfers. A trial with a 4-hour window would permit enrollment of 67% of the ischemic strokes, 82% of intracranial hemorrhage cases, and 76% of MI patients.
CONCLUSIONS: Clinical trials are feasible during aerial interhospital transport of patients. Flight nurses became successful investigators in clinical research and were exposed to potentially eligible patients with the ability to consent either directly or through surrogates. This approach could improve current clinical trial recruitment in rural areas, as well as permit testing of inflight ancillary interventions to improve outcome during patient transport.