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)

Oriol Roca, Oriol Caritg, Manel Santafé, Francisco J Ramos, Andrés Pacheco, Marina García-de-Acilu, Ricard Ferrer, Marcus J Schultz, Jean-Damien Ricard, Oriol Roca, Oriol Caritg, Manel Santafé, Francisco J Ramos, Andrés Pacheco, Marina García-de-Acilu, Ricard Ferrer, Marcus J Schultz, Jean-Damien Ricard

Abstract

Background: We aimed to assess the efficacy of a closed-loop oxygen control in critically ill patients with moderate to severe acute hypoxemic respiratory failure (AHRF) treated with high flow nasal oxygen (HFNO).

Methods: In this single-centre, single-blinded, randomized crossover study, adult patients with moderate to severe AHRF who were treated with HFNO (flow rate ≥ 40 L/min with FiO2 ≥ 0.30) were randomly assigned to start with a 4-h period of closed-loop oxygen control or 4-h period of manual oxygen titration, after which each patient was switched to the alternate therapy. The primary outcome was the percentage of time spent in the individualized optimal SpO2 range.

Results: Forty-five patients were included. Patients spent more time in the optimal SpO2 range with closed-loop oxygen control compared with manual titrations of oxygen (96.5 [93.5 to 98.9] % vs. 89 [77.4 to 95.9] %; p < 0.0001) (difference estimate, 10.4 (95% confidence interval 5.2 to 17.2). Patients spent less time in the suboptimal range during closed-loop oxygen control, both above and below the cut-offs of the optimal SpO2 range, and less time above the suboptimal range. Fewer number of manual adjustments per hour were needed with closed-loop oxygen control. The number of events of SpO2 < 88% and < 85% were not significantly different between groups.

Conclusions: Closed-loop oxygen control improves oxygen administration in patients with moderate-to-severe AHRF treated with HFNO, increasing the percentage of time in the optimal oxygenation range and decreasing the workload of healthcare personnel. These results are especially relevant in a context of limited oxygen supply and high medical demand, such as the COVID-19 pandemic. Trial registration The HILOOP study was registered at www.

Clinicaltrials: gov under the identifier NCT04965844 .

Keywords: Acute respiratory failure; Automatic oxygen titration; Closed-loop oxygen control; High flow nasal cannula; High-flow nasal oxygen; Nasal high-flow.

Conflict of interest statement

OR discloses a research grant from Hamilton Medical AG and speaker fees from Hamilton Medical AG, Ambu, Aerogen Ltd, and Fisher&Paykel Healthcare Ltd, and non-financial research support from Timpel and Massimo Corporation. RF discloses personal fees from MSD, Pfizer, Shionogi, Gilead, Grifols, Menarini, and GSK. MJS discloses speaker fees from Hamilton Medical AG. JDR discloses travel expenses from Fisher&Paykel Healthcare Ltd. All other authors disclose no conflict of interest.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flow chart of the patients screened, randomized and included
Fig. 2
Fig. 2
Comparison of SpO2 values between closed-loop oxygen control and manual oxygen titration. A Percentage of time in the optimal range. B Percentage of time spent in optimal, suboptimal ranges and out of range. For illustrative purposes, the height of each bar of B represents the mean of the values

References

    1. Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, et al. Physiologic effects of high-flow nasal cannula in acute hypoxemic respiratory failure. Am J Respir Crit Care Med. 2017;195(9):1207–1215. doi: 10.1164/rccm.201605-0916OC.
    1. Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010;55(4):408–413.
    1. Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, et al. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020;46(12):2238–2247. doi: 10.1007/s00134-020-06228-7.
    1. Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, et al. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019;45(5):563–572.
    1. Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, et al. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020;46(12):2226–2237. doi: 10.1007/s00134-020-06312-y.
    1. O'Driscoll BR, Howard LS, Earis J, Mak V. BTS guideline for oxygen use in adults in healthcare and emergency settings. Thorax. 2017;72(Suppl 1):ii1–ii90. doi: 10.1136/thoraxjnl-2016-209729.
    1. 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):187–195. doi: 10.1097/CCM.0000000000002084.
    1. Helmerhorst HJ, Roos-Blom MJ, van Westerloo DJ, de Jonge E. Association between arterial hyperoxia and outcome in subsets of critical illness: a systematic review, meta-analysis, and meta-regression of cohort studies. Crit Care Med. 2015;43(7):1508–1519. doi: 10.1097/CCM.0000000000000998.
    1. Palmer E, Post B, Klapaukh R, Marra G, MacCallum NS, Brealey D, et al. The association between supraphysiologic arterial oxygen levels and mortality in critically ill patients. A multicenter observational cohort study. Am J Respir Crit Care Med. 2019;200(11):1373–1380. doi: 10.1164/rccm.201904-0849OC.
    1. Damiani E, Adrario E, Girardis M, Romano R, Pelaia P, Singer M, et al. Arterial hyperoxia and mortality in critically ill patients: a systematic review and meta-analysis. Crit Care. 2014;18(6):711. doi: 10.1186/s13054-014-0711-x.
    1. Pala Cifci S, Urcan Tapan Y, Turemis Erkul B, Savran Y, Comert B. The impact of hyperoxia on outcome of patients treated with noninvasive respiratory support. Can Respir J. 2020;2020:3953280. doi: 10.1155/2020/3953280.
    1. Arnal JM, Garnero A, Novotni D, Corno G, Donati SY, Demory D, et al. Closed loop ventilation mode in Intensive Care Unit: a randomized controlled clinical trial comparing the numbers of manual ventilator setting changes. Minerva Anestesiol. 2018;84(1):58–67. doi: 10.23736/S0375-9393.17.11963-2.
    1. L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, et al. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017;50(1):1602552. doi: 10.1183/13993003.02552-2016.
    1. Harper JC, Kearns NA, Maijers I, Bird GE, Braithwaite I, Shortt NP, et al. Closed-loop oxygen control using a novel nasal high-flow device: a randomized crossover trial. Respir Care. 2021;66(3):416–424. doi: 10.4187/respcare.08087.
    1. 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. doi: 10.1183/13993003.00182-2020.
    1. Ouanes I, Bouhaouala F, Maatouk S, Lahmar M, Ben Abdallah S, Hammouda Z, et al. Automatic oxygen administration and weaning in patients following mechanical ventilation. J Crit Care. 2021;61:45–51. doi: 10.1016/j.jcrc.2020.10.005.
    1. 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. doi: 10.1136/bmjresp-2020-000843.
    1. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021;47(1):60–73.
    1. Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals. Crit Care. 2021;25(1):421.
    1. Zucman N, Mullaert J, Roux D, Roca O, Ricard JD. Prediction of outcome of nasal high flow use during COVID-19-related acute hypoxemic respiratory failure. Intensive Care Med. 2020;46(10):1924–1926. doi: 10.1007/s00134-020-06177-1.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernández G, et al. An index combining respiratory rate and oxygenation to predict outcome of nasal high-flow therapy. Am J Respir Crit Care Med. 2019;199(11):1368–1376. doi: 10.1164/rccm.201803-0589OC.
    1. Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, et al. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: the utility of the ROX index. J Crit Care. 2016;35:200–205. doi: 10.1016/j.jcrc.2016.05.022.
    1. Hodges J, Lehmann E. Estimates of location based on rank tests. Ann Math Stat. 1963;34:13. doi: 10.1214/aoms/1177704172.
    1. R Core Team. R: a language and environment for statistical computing. R Foundation for Statistical Computing; 2020. .
    1. Wickham H. ggplot2: elegant graphics for data analysis. Springer; 2016.
    1. Wickham H, Averick M, Bryan J, Chang W, McGowan L, François R, et al. Welcome to the tidyverse. J Open Source Softw. 2019;4(43):1686. doi: 10.21105/joss.01686.
    1. Sergeant E. Epitools epidemiological calculators. Ausvet; 2018.
    1. Lellouche F, Bouchard PA, Roberge M, Simard S, L'Her E, Maltais F, et al. Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial. Int J Chron Obstruct Pulmon Dis. 2016;11:1983–1990. doi: 10.2147/COPD.S112820.
    1. Penoyer DA. Nurse staffing and patient outcomes in critical care: a concise review. Crit Care Med. 2010;38(7):1521–1528. doi: 10.1097/CCM.0b013e3181e47888.
    1. Bruyneel A, Tack J, Droguet M, Maes J, Wittebole X, Miranda DR, et al. Measuring the nursing workload in intensive care with the Nursing Activities Score (NAS): a prospective study in 16 hospitals in Belgium. J Crit Care. 2019;54:205–211. doi: 10.1016/j.jcrc.2019.08.032.
    1. Schultz MJ, Roca O, Shrestha GS. Global lessons learned from COVID-19 mass casualty incidents. Br J Anaesth. 2022;128(2):e97–e100. doi: 10.1016/j.bja.2021.10.040.
    1. Poncin W, Baudet L, Reychler G, Duprez F, Liistro G, Belkhir L, et al. Impact of an improvised system on preserving oxygen supplies in patients with COVID-19. Arch Bronconeumol. 2021;57:77–79. doi: 10.1016/j.arbres.2020.07.019.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir