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Ringing a bell in healthcare: harnessing benefits, overcoming implementation challenges, and bridging knowledge gaps of Closed-Loop Oxygen Control systems (CLOCs)

Dear Editor,

The World Health Organization has listed oxygen as an essential medicine.(11. World Health Organization (WHO). WHO Model List of Essential Medicines - 23rd list, 2023. Geneva: WHO; 2023 [cited 2023 Sep 28]. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
https://www.who.int/publications/i/item/...
) Commonly prescribed for hospitalized pediatric and adult patients, there is a wide opportunity to improve its effectiveness by promoting the more rational, sustainable, and safe use of supplemental oxygen.(22. de Jonge E, Peelen L, Keijzers PJ, Joore H, de Lange D, van der Voort PH, et al. Association between administered oxygen, arterial partial oxygen pressure and mortality in mechanically ventilated intensive care unit patients. Crit Care. 2008;12(6):R156.,33. Helmerhorst HJ, Arts DL, Schultz MJ, van der Voort PH, Abu-Hanna A, de Jonge E, et al. Metrics of Arterial Hyperoxia and Associated Outcomes in Critical Care. Crit Care Med. 2017;45(2):187-95.) Guidelines and recommendations for oxygen use may help healthcare workers to adopt and achieve specific oxygen targets,(44. O’Driscoll BR, Howard LS, Earis J, Mak V; British Thoracic Society Emergency Oxygen Guideline Group; BTS Emergency Oxygen Guideline Development Group. BTS guideline for oxygen use in adults in healthcare and emergency settings. Thorax. 2017;72(Suppl 1):ii1-ii90. Review.) mitigating hyperoxemia, and hypoxemia.(44. O’Driscoll BR, Howard LS, Earis J, Mak V; British Thoracic Society Emergency Oxygen Guideline Group; BTS Emergency Oxygen Guideline Development Group. BTS guideline for oxygen use in adults in healthcare and emergency settings. Thorax. 2017;72(Suppl 1):ii1-ii90. Review.,55. Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022;387(19):1759-69.) Staying within safe targets, however, can be challenging, and is also quite time-consuming and labor-intensive, as it requires intensive monitoring and constant manual adjustments of the oxygen flow rate.(66. Denault MH, Péloquin F, Lajoie AC, Lacasse Y. Automatic versus Manual Oxygen Titration in Patients Requiring Supplemental Oxygen in the Hospital: a Systematic Review and Meta-Analysis. Respiration. 2019;98(2):178-88.,77. Sanchez-Morillo D, Olaby O, Fernandez-Granero MA, Leon-Jimenez A. Physiological closed-loop control in intelligent oxygen therapy: a review. Comput Methods Programs Biomed. 2017;146:101-08. Review.) Delays in response time, missing care, and human errors are clear challenges(88. Tubbs-Cooley HL, Mara CA, Carle AC, Mark BA, Pickler RH. Association of Nurse Workload With Missed Nursing Care in the Neonatal Intensive Care Unit. JAMA Pediatr. 2019;173(1):44-51.) and even short episodes of hypoxemia and hyperoxemia can be critical for specific populations in whom deviations from optimal SpO2 ranges can occur often and quickly.

Closed-loop oxygen control systems (CLOCs) have the potential to optimize oxygen flow titration, prevent hypoxemia and hyperoxemia, and reduce oxygen waste.(66. Denault MH, Péloquin F, Lajoie AC, Lacasse Y. Automatic versus Manual Oxygen Titration in Patients Requiring Supplemental Oxygen in the Hospital: a Systematic Review and Meta-Analysis. Respiration. 2019;98(2):178-88.,77. Sanchez-Morillo D, Olaby O, Fernandez-Granero MA, Leon-Jimenez A. Physiological closed-loop control in intelligent oxygen therapy: a review. Comput Methods Programs Biomed. 2017;146:101-08. Review.) With CLOCs, oxygen flow is titrated against continuously monitored SpO2 readings and target preset SpO2 ranges.(66. Denault MH, Péloquin F, Lajoie AC, Lacasse Y. Automatic versus Manual Oxygen Titration in Patients Requiring Supplemental Oxygen in the Hospital: a Systematic Review and Meta-Analysis. Respiration. 2019;98(2):178-88.,77. Sanchez-Morillo D, Olaby O, Fernandez-Granero MA, Leon-Jimenez A. Physiological closed-loop control in intelligent oxygen therapy: a review. Comput Methods Programs Biomed. 2017;146:101-08. Review.,99. Rush B, Celi LA, Stone DJ. Applying machine learning to continuously monitored physiological data. J Clin Monit Comput. 2019;33(5):887-93. Review.) Closed-Loop Oxygen Control systems have already found their way into certain medical devices such as ventilators,(1010. L’Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, et al. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study. Eur Respir J. 2021;57(1):2000182.) low-flow oxygen therapy devices,(1111. Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic® during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018;13:3997-4003.) and high-flow oxygen therapy systems.(1212. Roca O, Caritg O, Santafé M, Ramos FJ, Pacheco A, García-de-Acilu M, et al. Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen: a randomized cross-over study (the HILOOP study). Crit Care. 2022;26(1):108.)

Closed-Loop Oxygen Control systems not only have the potential to improve patient outcomes,(66. Denault MH, Péloquin F, Lajoie AC, Lacasse Y. Automatic versus Manual Oxygen Titration in Patients Requiring Supplemental Oxygen in the Hospital: a Systematic Review and Meta-Analysis. Respiration. 2019;98(2):178-88.,77. Sanchez-Morillo D, Olaby O, Fernandez-Granero MA, Leon-Jimenez A. Physiological closed-loop control in intelligent oxygen therapy: a review. Comput Methods Programs Biomed. 2017;146:101-08. Review.) but may also reduce the workloads that come with rational, sustainable, and safe use of supplemental oxygen.(66. Denault MH, Péloquin F, Lajoie AC, Lacasse Y. Automatic versus Manual Oxygen Titration in Patients Requiring Supplemental Oxygen in the Hospital: a Systematic Review and Meta-Analysis. Respiration. 2019;98(2):178-88.,77. Sanchez-Morillo D, Olaby O, Fernandez-Granero MA, Leon-Jimenez A. Physiological closed-loop control in intelligent oxygen therapy: a review. Comput Methods Programs Biomed. 2017;146:101-08. Review.) The time saved by CLOCs may further allow healthcare workers to focus on other activities related to patient care, where the presence of healthcare professionals is even more decisive.(66. Denault MH, Péloquin F, Lajoie AC, Lacasse Y. Automatic versus Manual Oxygen Titration in Patients Requiring Supplemental Oxygen in the Hospital: a Systematic Review and Meta-Analysis. Respiration. 2019;98(2):178-88.,1212. Roca O, Caritg O, Santafé M, Ramos FJ, Pacheco A, García-de-Acilu M, et al. Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen: a randomized cross-over study (the HILOOP study). Crit Care. 2022;26(1):108.) While the safety and efficacy of CLOCs have been extensively studied, evidence of their cost-effectiveness remains to be determined.(1313. Poder TG, Kouakou CR, Bouchard PA, Tremblay V, Blais S, Maltais F, et al. Cost-effectiveness of FreeO2 in patients with chronic obstructive pulmonary disease hospitalised for acute exacerbations: analysis of a pilot study in Quebec. BMJ Open. 2018;8(1):e018835.)

The demand for oxygen can easily outstrip the supply, and the lack of available oxygen can be a serious problem faced by healthcare systems worldwide, as highlighted recently by the coronavirus disease (COVID-19) pandemic.(1414. Usher AD. Medical oxygen crisis: a belated COVID-19 response. Lancet. 2021;397(10277):868-9.,1515. Botta M, Caritg O, van Meenen DM, Pacheco A, Tsonas AM, Mooij WE, et al. Oxygen Consumption with High-Flow Nasal Oxygen versus Mechanical Ventilation- An International Multicenter Observational Study in COVID-19 Patients (PROXY-COVID). Am J Trop Med Hyg. 2023;108(5):1035-41.) Oxygen scarcity situations can be favorable for CLOCs adoption, as they have a strong potential to reduce waste and optimize the overall usage of supplemental oxygen.1212. Roca O, Caritg O, Santafé M, Ramos FJ, Pacheco A, García-de-Acilu M, et al. Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen: a randomized cross-over study (the HILOOP study). Crit Care. 2022;26(1):108.,11. World Health Organization (WHO). WHO Model List of Essential Medicines - 23rd list, 2023. Geneva: WHO; 2023 [cited 2023 Sep 28]. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
https://www.who.int/publications/i/item/...
An important benefit to be considered in the introduction of CLOCs is their potential to reduce the workload of healthcare professionals, offering a way to partially offload certain responsibilities and help make healthcare systems more efficient.

However, implementing CLOCs in daily care is critical. Although the incorporation of automated technologies at the bedside has demonstrated promising results regarding effectiveness, evidence for patient benefits is probably absent. Another under-discussed topic is the discrepancy and inequitable access to CLOCs devices between high- and middle-income countries. The most updated technologies are frequently available in high-performance organizations. However, this creates an unrealistic scenario for most healthcare institutions worldwide.

Additional studies are required to provide further insights. Effectiveness studies are no longer required once they have been extensively discussed. Closed-Loop Oxygen Control systems perform well and, as expected, outperform healthcare workers. Future studies should focus on cost-effectiveness, workload effects, and implementation in clinical practice to fully examine these topics.

ACKNOWLEDGMENTS

Marcus J. Schultz was the team leader in Research and New Technologies at Hamilton Medical AG, Bonaduz, Switzerland, from January 2022 to January 2023.

REFERENCES

  • 1
    World Health Organization (WHO). WHO Model List of Essential Medicines - 23rd list, 2023. Geneva: WHO; 2023 [cited 2023 Sep 28]. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
    » https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
  • 2
    de Jonge E, Peelen L, Keijzers PJ, Joore H, de Lange D, van der Voort PH, et al. Association between administered oxygen, arterial partial oxygen pressure and mortality in mechanically ventilated intensive care unit patients. Crit Care. 2008;12(6):R156.
  • 3
    Helmerhorst HJ, Arts DL, Schultz MJ, van der Voort PH, Abu-Hanna A, de Jonge E, et al. Metrics of Arterial Hyperoxia and Associated Outcomes in Critical Care. Crit Care Med. 2017;45(2):187-95.
  • 4
    O’Driscoll BR, Howard LS, Earis J, Mak V; British Thoracic Society Emergency Oxygen Guideline Group; BTS Emergency Oxygen Guideline Development Group. BTS guideline for oxygen use in adults in healthcare and emergency settings. Thorax. 2017;72(Suppl 1):ii1-ii90. Review.
  • 5
    Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022;387(19):1759-69.
  • 6
    Denault MH, Péloquin F, Lajoie AC, Lacasse Y. Automatic versus Manual Oxygen Titration in Patients Requiring Supplemental Oxygen in the Hospital: a Systematic Review and Meta-Analysis. Respiration. 2019;98(2):178-88.
  • 7
    Sanchez-Morillo D, Olaby O, Fernandez-Granero MA, Leon-Jimenez A. Physiological closed-loop control in intelligent oxygen therapy: a review. Comput Methods Programs Biomed. 2017;146:101-08. Review.
  • 8
    Tubbs-Cooley HL, Mara CA, Carle AC, Mark BA, Pickler RH. Association of Nurse Workload With Missed Nursing Care in the Neonatal Intensive Care Unit. JAMA Pediatr. 2019;173(1):44-51.
  • 9
    Rush B, Celi LA, Stone DJ. Applying machine learning to continuously monitored physiological data. J Clin Monit Comput. 2019;33(5):887-93. Review.
  • 10
    L’Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, et al. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study. Eur Respir J. 2021;57(1):2000182.
  • 11
    Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic® during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018;13:3997-4003.
  • 12
    Roca O, Caritg O, Santafé M, Ramos FJ, Pacheco A, García-de-Acilu M, et al. Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen: a randomized cross-over study (the HILOOP study). Crit Care. 2022;26(1):108.
  • 13
    Poder TG, Kouakou CR, Bouchard PA, Tremblay V, Blais S, Maltais F, et al. Cost-effectiveness of FreeO2 in patients with chronic obstructive pulmonary disease hospitalised for acute exacerbations: analysis of a pilot study in Quebec. BMJ Open. 2018;8(1):e018835.
  • 14
    Usher AD. Medical oxygen crisis: a belated COVID-19 response. Lancet. 2021;397(10277):868-9.
  • 15
    Botta M, Caritg O, van Meenen DM, Pacheco A, Tsonas AM, Mooij WE, et al. Oxygen Consumption with High-Flow Nasal Oxygen versus Mechanical Ventilation- An International Multicenter Observational Study in COVID-19 Patients (PROXY-COVID). Am J Trop Med Hyg. 2023;108(5):1035-41.
  • 16
    Harper J, Kearns N, Bird G, Braithwaite I, Eathorne A, Shortt N, et al. Automatic versus manual oxygen titration using a novel nasal high-flow device in medical inpatients with an acute illness: a randomised controlled trial. BMJ Open Respir Res. 2021;8(1):e000843.
  • This study was conducted without funding.
Associate Editor: Kenneth Gollob Hospital Israelita Albert Einstein, São Paulo, SP, Brazil ORCID: https://orcid.org/0000-0003-4184-3867

Publication Dates

  • Publication in this collection
    25 Mar 2024
  • Date of issue
    2024

History

  • Received
    19 Dec 2023
  • Accepted
    08 Jan 2024
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