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- Jeffrey A Kline, Jackeline Hernandez, John S Garrett, and Alan E Jones.
- Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.
- Emerg Med J. 2014 Jun 1; 31 (6): 459-62.
ObjectiveInhaled nitric oxide has been reported to benefit patients with acute pulmonary embolism (PE). To date, all published literature has derived from case reports or case series conducted without a structured protocol. Here we report the results of a phase I trial with a predefined clinical protocol to treat patients with CT-demonstrated, submassive PE and moderate to severe dyspnoea.MethodsPatients were recruited from the emergency department of an academic teaching hospital. Informed consent and the entire treatment protocol was administered by a study physician. Nitric oxide was administered using a commercial device (Inovent) and a custom-made non-rebreathing face mask. The NO concentration was increased at 1 ppm/min (parts per million) until a maximum of 25 ppm and continued for 120 min and then weaned at 1 ppm/min. Dyspnoea was assessed with the Borg score, oxygenation by pulse oximetry, and haemodynamic status by shock index (HR/SBP).ResultsEight patients were enrolled. All patients tolerated the entire protocol without adverse events, and all had decreased numerical Borg score by >50%. The changes from baseline to 155 min were as follows: Borg score 7.5±2.5 to 2.3±1.9 (p=0.06, Signed rank test), SaO2% 93±5 to 97±3 and shock index 1.0±0.11 to 0.86±0.09. No patient experienced worsening during weaning.ConclusionsInhaled NO reduced dyspnoea without adverse events in eight patients with severe submassive PE. This protocol can serve as the basis for a phase II trial or for a compassionate use protocol.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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