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      Automated versus manual oxygen titration in COPD exacerbation: machine or hands, this is the question

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          Abstract

          Dear editor We have read the article titled “Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial” by Lellouche et al with great interest; however, there are some key aspects to take into account for proper practical implications.1 First, regarding ethical aspects, there seem to be some confusing points about disclosure and researchers. Of the researchers, one is a co-inventor of company that developed the device and two are owners of free oxygen generator. We could not clarify whether any of the authors are medical doctors. With regard to other aspects in the manuscript, the study included COPD patients (aged >40 years) with exacerbation and resting saturation <90% at room environment in whom SpO2 increased to <92% by 8 L/min oxygen supplementation. It was mentioned that it was impossible to obtain informed consent from patients who stayed in the hospital for >24 h, those with antibiotic-resistant infection, those who underwent intermittent nonintensive ventilation, and those with cognitive dysfunction. Also, the authors did not mention comorbid conditions, body mass index, exercise capacity, duration of COPD, current therapies received, and, most importantly, whether there is comorbid heart failure in the patients.2 The authors performed pulmonary function tests by post-bronchodilator spirometry; however, they did not take COPD grade (mild/moderate/severe) into account during standardization.3 In addition, there were no data regarding concurrent therapies given at emergency department and during admission. Did all patients undergo a standard treatment protocol? Moreover, patients of a broad range of age were included in the study. Thus, it is impossible to have no variations in exercise capacity, cognitive functions, and treatment response in this wide range of age from 40 to 80 years. The finding that use of free oxygen device was only an effective factor in improved saturation and shortened length of hospital stay by neglecting many parameters arises some questions about the results obtained in this study. In the limitations, the authors mentioned that sample size per group was small. However, no power analysis was performed. It was reported that the principal investigators were not involved in the care and disposition of study patients and that emergency room clinicians and nurses performed works related to the study; however, it was impossible that clinicians and nurses involved in the study were blind to study. Thus, the bias in the patient selection and management is controversial. In conclusion, the study should have to be performed on selected patients by independent clinicians without funding.

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          Most cited references 10

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          Automated closed loop control of inspired oxygen concentration.

          Oxygen therapy is extensively used in premature infants and adults with respiratory insufficiency. In the premature infant the goal during manual control of the F(IO(2)) is to maintain adequate oxygenation and to minimize the exposure to hypoxemia, hyperoxemia, and oxygen. However, this is frequently not achieved during routine care, which increases the risks of associated side effects affecting the eye, lungs, and central nervous system. In the adult the primary goal is to avoid hypoxemia, but conventional methods of oxygen supplementation may fall short during periods of increased demand. On the other hand, there are growing concerns related to unnecessarily high F(IO(2)) levels that increase the exposure to hyperoxemia and excessive oxygen use in settings where resources are limited. Systems for automated closed loop control of F(IO(2)) have been developed for use in neonates and adults. This paper will give an overview of the rationale for the development of these systems, present the evidence, and discuss important advantages and limitations.
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            Automated oxygen flow titration to maintain constant oxygenation.

            One century after the introduction of the oxygen flow meter into clinical practice, we have developed a device, FreeO(2), that automatically titrates the oxygen flow delivered to spontaneously breathing patients, with the aim of maintaining a stable S(pO(2)). We evaluated this system in healthy subjects during induced hypoxemia. Hypoxemia was induced in 10 healthy subjects while breathing a gas mixture of variable F(IO(2)) (air + nitrogen). Each subject performed 3 hypoxemic challenges with the addition, in a random order, of either: air with constant flow (1.5 L/min); oxygen with constant flow (1.5 L/min); or automatic oxygen flow titration. Subjects were blinded to the intervention. Oxygen flow, S(pO(2)), end-tidal CO(2), respiratory rate, and heart rate were recorded every second. The primary outcome was the time with S(pO(2)) between 92% and 96%. The S(pO(2)) target (92-96%) was achieved a median of 26.0%, 36.8%, and 66.5% (P < .001) of the time with air, constant oxygen, and automated oxygen titration, respectively. Severe oxygen desaturations (S(pO(2)) < 88%) were respectively observed at a median of 33.7%, 12.7%, and 0.4% of the time (P < .001). Hyperoxia was present a median of 4.1%, 39.1%, and 14.5% of the time (P < .001). Tachycardia was present with air and with constant oxygen flow, but not while using automated oxygen titration. These results were obtained with a mean and maximal oxygen flow of 1.3 L/min and 7.6 L/min with the automated titration. In this model of induced hypoxemia, the FreeO(2) system that automatically titrates the oxygen flow was more efficient at maintaining the S(pO(2)) target, while ensuring a statistically significant reduction in the rates of severe hypoxemia and hyperoxia, in comparison with air or constant oxygen flow. These beneficial results were obtained with less oxygen, in comparison to a constant oxygen flow.
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              Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial

              Introduction We developed a device (FreeO2) that automatically adjusts the oxygen flow rates based on patients’ needs, in order to limit hyperoxia and hypoxemia and to automatically wean them from oxygen. Objective The aim of this study was to evaluate the feasibility of using FreeO2 in patients hospitalized in the respiratory ward for an acute exacerbation of COPD. Methods We conducted a randomized controlled trial comparing FreeO2 vs manual oxygen titration in the respiratory ward of a university hospital. We measured the perception of appropriateness of oxygen titration and monitoring in both groups by nurses and attending physicians using a Likert scale. We evaluated the time in the target range of oxygen saturation (SpO2) as defined for each patient by the attending physician, the time with severe desaturation (SpO2 5% above the target). We also recorded length of stay, intensive care unit admissions, and readmission rate. Fifty patients were randomized (25 patients in both groups; mean age: 72±8 years; mean forced expiratory volume in 1 second: 1.00±0.49 L; and mean initial O2 flow 2.0±1.0 L/min). Results Nurses and attending physicians felt that oxygen titration and monitoring were equally appropriate with both O2 administration systems. The percentage of time within the SpO2 target was significantly higher with FreeO2, and the time with severe desaturation and hyperoxia was significantly reduced with FreeO2. Time from study inclusion to hospital discharge was 5.8±4.4 days with FreeO2 and 8.4±6.0 days with usual oxygen administration (P=0.051). Conclusion FreeO2 was deemed as an appropriate oxygen administration system by nurses and physicians of a respiratory unit. This system maintained SpO2 at the target level better than did manual titration and reduced periods of desaturation and hyperoxia. Our results also suggest that FreeO2 has the potential to reduce the hospital length of stay.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2017
                03 April 2017
                : 12
                : 1057-1060
                Affiliations
                [1 ]Department of Anesthesiology and Reanimation, Istanbul Umraniye Research Hospital, Istanbul, Turkey
                [2 ]Intensive Care Unit, Hospital Morale Meseguer, Murcia, Spain
                Centre de Recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Quebec City, Quebec, Canada
                Author notes
                Correspondence: Gulsah Karaoren, Department of Anesthesiology and Reanimation, Istanbul Umraniye Research Hospital, Istanbul, Turkey, Tel +90 505 357 3121, Email drgyilmaz@ 123456yahoo.com
                Correspondence: François Lellouche, Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, 2725 Chemin Ste-Foy, Quebec City G1V 4G5, QC, Canada, Tel +1 418 656 8711 ext 3298, Email francois.lellouche@ 123456criucpq.ulaval.ca
                Article
                copd-12-1057
                10.2147/COPD.S130107
                5388255
                © 2017 Karaoren et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Letter

                Respiratory medicine

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