PB980; complications; critical care; respiratory distress; safety; ventilation; Complication; Data collection; Mechanical ventilation; Real-world; Relative frequencies; System safety; Systems performance; Ventilator systems; Medicine (miscellaneous); Biomedical Engineering
Abstract :
[en] [en] PURPOSE: Mechanical ventilation is a life-supporting intervention but is associated with known risks and complications. To improve the efficacy and safety profile of mechanical ventilation, manufacturers have developed advanced ventilator settings, modes, and alarm strategies to optimize ventilation for patient needs while avoiding complications. However, there is little real-world data published on the deployment of ventilator technology. The main objective of this study was to assess the clinical safety and performance of the Puritan Bennett™ 980 Ventilator System (PB980) using real-world clinical data collected from a diverse, global patient population.
METHODS: This was a multi-center, post-market registry study that included nine sites: four in the United States of America, one in Europe, and four in China. Patients were enrolled into the registry if they were intended to be treated with a PB980. Data collection began at the start of ventilation and continued until extubation off the ventilator or up to seven days of ventilation, whichever occurred first. Subjects were divided by age into three categories: infants (0-365 days), pediatric (1-17 years), and adult (18 years and older). The primary outcome was device-related complication rate.
RESULTS: Two-hundred-and-eleven subjects were enrolled (41 infants, 48 pediatric, and 122 adults). Sixteen deaths, unrelated to device deficiency, occurred during the data collection timeframe (relative frequency: 7.58, 95% CI: 4.40, 12.0). Only one device-related adverse event was reported (relative frequency: 0.47% 95% CI: 0.01%, 2.61%).
CONCLUSION: Ventilation by the PB980 was delivered safely in this multi-center observational study, which included a diverse sample of patients with broad ventilatory needs.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Roshon, Michael; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado, Springs, CO, USA
Khandhar, Paras B; Pediatric Critical Care Medicine, Beaumont Children's Hospital, Royal Oak, MI, USA
Biniwale, Manoj ; Division of Neonatology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA
Ramanathan, Rangasamy; Division of Neonatology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA
Frazier, T Patrick; Department of Medicine, University of Alabama at Birmingham, Heersink School of Medicine, Birmingham, AL, USA
Xu, Feng; Department of Intensive Care, Children's Hospital of Chongqing Medical University, Chongqing, People's Republic of China
Zhang, Linlin; Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, People's Republic of China
Guan, Xiangdong; Department of Critical Care Medicine, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China
Wenling, Dai; Department of Critical Care Medicine, Yancheng First People's Hospital, Yancheng, People's Republic of China
Lambermont, Bernard ; Université de Liège - ULiège > Département des sciences cliniques > Sémiologie
Language :
English
Title :
Evaluation of the Puritan Bennett™ 980 Ventilator System Safety and Performance in the Real-World Setting.
Data was collected from the PB980 Post-Approval Registry, a prospective, observational, multinational study conducted from June 2020 to April 2022 in the United States of America (USA), Europe, and China (Table 1). Enrollment in the study did not impact the care patients received before, during, or after participation. Study procedures were performed in accordance with the Declaration of Helsinki under a protocol that was duly approved by the Institutional Review Board or Ethics Committee (IRB/EC), as applicable, at each site. This study was sponsored and supported by Medtronic (Minneapolis, MN).Study execution support was provided by Katherine Schiller, Naomi Wang, Demarcus Williams, and Ryan Zhou of Medtronic, Elizabeth Kring and Christine Batchelder of Beaumont Children’s, and Nathan Dureg and Kate Ramm of University of Southern California General Medical Center. Biostatistical analysis and support was provided by Anne Sexter, Guang Yang, Hui Xiong, and Julia Yang of Medtronic. Medical writing support was provided by Hanan Zavala of Medtronic in accordance with Good Publication Practice (GPP 2022) guidelines.28 An abstract of this work was accepted and presented at the Society of Critical Care Medicine 2024 Critical Care Congress (January 21 – 23, Phoenix Arizona).
Klompas M, Kleinman K, Murphy MV. Descriptive epidemiology and attributable morbidity of ventilator-associated events. Infect Control Hosp Epidemiol. 2014;35(5):502–510. doi:10.1086/675834
Silva PL, Ball L, Rocco PR, Pelosi P. Physiological and Pathophysiological Consequences of Mechanical Ventilation. Thieme Medical Publishers, Inc.; 2022.
Dexter AM, Clark K. Ventilator graphics: scalars, loops, & secondary measures. Respiratory Care. 2020;65(6):739–759. doi:10.4187/respcare.07805
Dos Santos Rocha A, Habre W, Albu G. Novel ventilation techniques in children. Pediatr Anesthesia. 2022;32(2):286–294. doi:10.1111/pan.14344
Pham T, Brochard LJ, Slutsky AS. Mechanical ventilation: state of the art. Elsevier. 2017;1382–1400.
Kacmarek RM. The mechanical ventilator: past, present, and future. Respiratory Care. 2011;56(8):1170–1180. doi:10.4187/respcare.01420
MacIntyre N, Rackley C, Khusid F. Fifty years of mechanical ventilation—1970s to 2020. Crit Care Med. 2021;49(4):558–574. doi:10.1097/CCM.0000000000004894
Egbuta C, Easley RB. Update on ventilation management in the Pediatric Intensive Care Unit. Pediatr Anesthesia. 2022;32(2):354–362. doi:10.1111/pan.14374
Beloncle F, Piquilloud L, Olivier PY, et al. Accuracy of P0.1 measurements performed by ICU ventilators: a bench study. Ann Intensive Care. 2019;9(1):104. doi:10.1186/s13613-019-0576-x
Itagaki T, Bennett DJ, Chenelle CT, Fisher DF, Kacmarek RM. Performance of Leak Compensation in All-Age ICU Ventilators During Volume-Targeted Neonatal Ventilation: a Lung Model Study. Respiratory Care. 2017;62(1):10–21. doi:10.4187/respcare.05012
Itagaki T, Chenelle CT, Bennett DJ, Fisher DF, Kacmarek RM. Effects of Leak Compensation on Patient-Ventilator Synchrony During Premature/ Neonatal Invasive and Noninvasive Ventilation: a Lung Model Study. Respiratory Care. 2017;62(1):22–33. doi:10.4187/respcare.04825
Koyama Y, Uchiyama A, Yoshida J, Yoshida T, Yamashita T, Fujino Y. A Comparison of the Adjustable Ranges of Inspiratory Pressurization During Pressure Controlled Continuous Mandatory Ventilation of 5 ICU Ventilators. Respiratory Care. 2018;63(7):849–858. doi:10.4187/respcare.05286
Krieger TJ, Wald M. Volume-targeted ventilation in the neonate: benchmarking ventilators on an active lung model. Pediatr Crit Care Med. 2017;18(3):241–248. doi:10.1097/PCC.0000000000001088
Moon K, Takeuchi M, Tachibana K, Mizuguchi S, Hirano S. Accuracy of Reported Tidal Volume During Neonatal Ventilation With Airway Leak: a Lung Model Study. Pediatr Crit Care Med. 2019;20(1):e37–e45. doi:10.1097/PCC.0000000000001752
Morita PP, Weinstein PB, Flewwelling CJ, et al. The usability of ventilators: a comparative evaluation of use safety and user experience. Crit Care. 2016;20(1):263. doi:10.1186/s13054-016-1431-1
Marjanovic NS, De Simone A, Jegou G, L’Her E. A new global and comprehensive model for ICU ventilator performances evaluation. Ann Intensive Care. 2017;7(1):68. doi:10.1186/s13613-017-0285-2
Di Paolo M, Evangelisti L, Ambrosino N. Unexpected death of a ventilator-dependent amyotrophic lateral sclerosis patient. Revista Portuguesa de Pneumologia. 2013;194:175–178. doi:10.1016/j.rppneu.2012.12.001
Kim K. Ventilator malfunction due to water condensation during low flow anaesthesia. Anaesthesia Intensive Care. 2011;39(6):1155.
Kumar BK, Ravi M, Dinesh K, Nanda A. Ventilator malfunction. J Anaesthesiol Clin Pharmacol. 2011;27(4):576. doi:10.4103/0970-9185.86623
Sripriya R, Parthasarathy S, Ravishankar M. Ventilator dysfunction: role of graphics in detection. Ain-Shams J Anaesthesiol. 2016;9(3):465. doi:10.4103/1687-7934.189103
Olayode A, Mashriqi N, Liu C, et al. 882: A Case of Ventilator Malfunction-Induced Pneumothorax. Crit Care Med. 2023;51(1):434. doi:10.1097/01.ccm.0000909256.95446.33
le Noble JL, Terpoorten FJ, der Snoek M, Foudraine N. Ventilator dysfunction due to unexpected salbutamol crystallisation while using a nebuliser: a practical advice for intensivists. Intensive Care Med Exp. 2022;10(1):1–3. doi:10.1186/s40635-022-00441-y
McEwan AI, Dowell AL, Karis JH. Bilateral tension pneumothorax caused by a blocked bacterial filter in an anesthesia breathing circuit. Anesthesia Analg. 1993;76(2):440–442.
Smith CE, Otworth JR, Kaluszyk P. Bilateral tension pneumothorax due to a defective anesthesia breathing circuit filter. J Clin Anesthesia. 1991;3 (3):229–234. doi:10.1016/0952-8180(91)90166-K
Kamio T, Masamune K. Mechanical ventilation-related safety incidents in general care wards and ICU settings. Respiratory Care. 2018;63 (10):1246–1252. doi:10.4187/respcare.06109
Pham JC, Williams TL, Sparnon EM, Cillie TK, Scharen HF, Marella WM. Ventilator-related adverse events: a taxonomy and findings from 3 incident reporting systems. Respiratory Care. 2016;61(5):621–631. doi:10.4187/respcare.04151
Cassidy C, Smith A, Arnot-Smith J. Critical incident reports concerning anaesthetic equipment: analysis of the UK National Reporting and Learning System (NRLS) data from 2006–2008. Anaesthesia. 2011;66(10):879–888. doi:10.1111/j.1365-2044.2011.06826.x
DeTora LM, Toroser D, Sykes A, et al. Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update. Ann Intern Med. 2022;175(9):1298–1304. doi:10.7326/m22-1460
