Original contributions
Efficacy and safety in patients on a resuscitator, oxylator EM-100, in comparison with a bag-valve device1

https://doi.org/10.1016/j.ajem.2004.08.020Get rights and content

Abstract

The purpose of this study was to compare the OxylatorEM-100, a ventilator with a fixed flow and working pressure of 25 to 50 cm H2O, with a bag-valve device with respect to safety, efficiency, and efficacy when used by professionals. We conducted a prospective, controlled, caregiver-blind single center study. Induction was followed by ventilation with a bag-valve device oxylator in manual and automatic modes. Steps were repeated under hypnosis, after muscle relaxation with mask, and with an endotracheal tube. Forty patients, aged 48.8 ± 13.5 years weighing 50 to 111 kg were studied. Airway management was consistently better with the bag-valve (P <.0001). Normocapnia was maintained with the bag-valve in 88%, oxylator (manual) in 73%, but only 14% of cases in automatic mode with tidal volumes of 1200 mL and more. This device was associated with the potential for rapid hyperventilation in patients when used by professionals. Simplicity of airway management was not improved.

Section snippets

Study design

The study was a prospective, controlled, caregiver-blind, single-center, clinical trial using a random selection of ASA 1 and 2 patients admitted for elective surgery under general anesthesia. The purpose of the study was to examine the efficacy, efficiency, and safety of one emergency ventilation device, the Oxylator EM-100, in comparison with bag-valve ventilation when used by professionals. The principal end points were to determine ease of airway management, achievement and maintenance of

Results

Forty patients were randomly approached and included after written informed consent was obtained. All patients completed the protocol without complications. Thirty patients were ventilated by the anesthesia nurse, the remainder by the paramedic. Of the 14 males included, 10 were ventilated by the anesthesia nurse. Weight was 73 ± 14 kg, with a range of 50 to 111 kg, age ranged from 23 to 76 years (49 ± 14) and height was 169 ± 12 cm. Body mass index was 25 ± 4, with 4 males and 10 females being

Discussion

Although a number of studies have addressed comparisons between bag-valve devices and other ventilatory devices, including oxygen driven ones, they often described small series of patients,9, 10 brief ventilatory periods,2, 8, 11, 12, 13, 19, 20 nonstandardized conditions with mixed groups,3, 4 and mixed experience of caregivers,17 or use of in vitro models.2, 6, 8, 10, 13, 19, 20, 23, 25 This study incorporated two professionals, each ventilating the patient over an extended period (≥40

Conclusion

The Oxylator EM-100 is a professional-level emergency ventilator, generating 40 L min−1 flow at a working pressure adjustable in the range of 25 to 50 cm H2O. It could be operated in a spontaneously breathing patient in manual and automatic ventilation modes. This apparatus is simple and effective in use and has commendable technology. The operator’s manual recommends 2-second ventilation periods leading almost consistently to hyperventilation when a mask is used or with an endotracheal tube in

Acknowledgements

The Oxylator EM-100 was supplied, free of charge, by The Surgical Company-Granulab, Amersfoort, NL.

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    Part of this data was reported before the European Resuscitation Council meeting at Antwerp, Belgium, June 2000.

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