BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial.

INTRODUCTION: Intubation-related complications are less frequent when intubation is successful on the first attempt. The rate of first attempt success in the emergency department (ED) and intensive care unit (ICU) is typically less than 90%. The bougie, a semirigid introducer that can be placed into the trachea to facilitate a Seldinger-like technique of tracheal intubation and is typically reserved for difficult or failed intubations, might improve first attempt success. Evidence supporting its use, however, is from a single academic ED with frequent bougie use. Validation of these findings is needed before widespread implementation. METHODS AND ANALYSIS: The BOugie or stylet in patients Undergoing Intubation Emergently trial is a prospective, multicentre, non-blinded randomised trial being conducted in six EDs and six ICUs in the USA. The trial plans to enrol 1106 critically ill adults undergoing orotracheal intubation. Eligible patients are randomised 1:1 for the use of a bougie or use of an endotracheal tube with stylet for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcome is severe hypoxaemia, defined as an oxygen saturation less than 80% between induction until 2 min after completion of intubation. Enrolment began on 29 April 2019 and is expected to be completed in 2021. ETHICS AND DISSEMINATION: The trial protocol was approved with waiver of informed consent by the Central Institutional Review Board at Vanderbilt University Medical Center or the local institutional review board at an enrolling site. The results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03928925).

Portable, consumer-grade pulse oximeters are accurate for home and medical use: Implications for use in the COVID-19 pandemic and other resource-limited environments.

OBJECTIVE: To determine the correlation between 3 lightweight portable pulse oximeter devices compared to a standard wall mount pulse oximetry device. METHODS: We performed a single-center, prospective, observational study of 4 pulse oximetry devices, 3 of which are commercially available to the public. A convenience sample of 200 emergency department (ED) patients with chief complaints of cardiopulmonary origin or a peripheral capillary oxygen saturation ≤ 94 percent were enrolled. Analysis of variance was performed to compare SpO2s and test characteristics of the 3 devices compared to control. RESULTS: Although differences in measured SpO2s were observed (P < 0.001) across groups, the differences were small (mean differences ranged from 1.00% to 1.87%). The correlation between test devices and the control were high (r range 0.70-0.79). Although the test characteristics were not perfect, the devices did have good sensitivity using a cutoff value of 94% (sensitivity ranging from 90% to 92%), which improved with lower SpO2 cutoff values to 92% (sensitivity ranging from 96% to 97%). CONCLUSION: The 3 commercially available devices were accurate enough to be clinically useful when compared to a hospital bedside monitor pulse oximeter. Consumer-grade portable pulse oximeters may be useful if overwhelming numbers of patients require oxygen saturation monitoring, such as during the COVID-19 pandemic.