TY - JOUR
T1 - Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen
T2 - a randomized cross-over study (the HILOOP study)
AU - Roca, Oriol
AU - Caritg, Oriol
AU - Santafé, Manel
AU - Ramos, Francisco J.
AU - Pacheco, Andrés
AU - García-de-Acilu, Marina
AU - Ferrer, Ricard
AU - Schultz, Marcus J.
AU - Ricard, Jean-Damien
N1 - Funding Information: This study is partially supported by a research grant from Hamilton Medical AG. For each patient, an anonymised file containing the recorded data from the high-flow device was sent to Hamilton Medical AG, where these data were transformed into a database of raw data and sent back to the investigators for further analysis. Hamilton Medical AG did not have a role in statistical analysis beyond this point or data interpretation. Funding Information: 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. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - 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.
AB - 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.
KW - Acute respiratory failure
KW - Automatic oxygen titration
KW - Closed-loop oxygen control
KW - High flow nasal cannula
KW - High-flow nasal oxygen
KW - Nasal high-flow
UR - http://www.scopus.com/inward/record.url?scp=85128325021&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13054-022-03970-w
DO - https://doi.org/10.1186/s13054-022-03970-w
M3 - Article
C2 - 35422002
SN - 1364-8535
VL - 26
JO - Critical Care
JF - Critical Care
IS - 1
M1 - 108
ER -