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ORI monitoring allows a reduction of time with hyperoxia in critically ill patients: the randomized control ORI2 study

  • Sigismond LasockiEmail author
  • Antoine Brochant
  • Maxime Leger
  • Thomas Gaillard
  • Pierre Lemarié
  • Soizic Gergaud
  • Pauline Dupré
Open Access
Letter

Dear Editor,

After decades of fear of hypoxia, it is now widely accepted that hyperoxia is deleterious too [1, 2]. This is the rationale for recent recommendations to target peripheral oxygen saturation (SpO2) ≤ 96% [3]. However, SpO2 monitoring may not be sufficient since elevated partial arterial oxygen pressure (PaO2) is not recognized once SpO2 ≥ 98%, indeed, critically ill patients may spend as much as 60% of the time with hyperoxia [4]. The oxygen reserve index (ORI), measured non-invasively by a pulse-oximeter, correlates to elevated PaO2 (for PaO2 > 80–100 mmHg [5]). We hypothesized that using ORI to set oxygen in critically ill patients would reduce the time with moderate hyperoxia (PaO2 ≥ 100 mmHg) compared to monitoring SpO2 (with upper limits) alone.

We randomized 150 adult patients, mechanically ventilated for a predictable duration ≥ 2 days to either ORI or control group (ClinicalTrial: NCT02878460; see esm). All the patients were monitored using Rainbow® pulse-oximeter sensors connected to ROOT monitors (MASIMO, USA). Nurses were instructed to decrease O2 rate when ORI was ≥ 0.01 (ORI group) or when SpO2 was ≥ prescribed upper limit (control group) (Supplementary Fig. 1e). Seventy-five patients were analyzed in the ORI group and 71 in the control group (Supplementary Fig. 2e). Patients in both groups were similar, except for the presence of shock at ICU admission (48 (64%) vs 32 (45%) in ORI and control groups, p = 0.022; Table 1e). Patients were most often admitted for urgent surgery and had frequent lung damage. The median duration of follow-up was similar (6 (2–13) vs 5 (2–16) days, p = 0.71). We analyzed 2455 arterial blood gasses, 1545 days and 36.929 h of oxygen therapy (medians 166 (56–306) vs 111 (40–396) h/patient for ORI and control groups, p = 0.58). ORI monitoring allowed a significant reduction in the percentage of days with hyperoxia (14 (0–33) vs 33 (11–56)% for ORI vs control, p = 0.003) without an increase in the percentage of days with hypoxia (Supplementary Fig. 3e). The percentage of time (in hours) spent with PaO2 ≥ 100 or ≥ 120 mmHg was also much lower using ORI (Table 1). We observed no statistically significant differences in mean daily PaO2 or FiO2, but the time spent with a FiO2 of 0.21 was greater in the ORI group (Table 1). There was no difference in any other clinical outcome.
Table 1

Main outcomes

 

ORI (n = 75)

Control (n = 71)

p

Primary outcomes

 Percentage of days with hyperoxia, %

14 (0–29)

28 (9–50)

0.003*

 Number of days with hyperoxia

1 (0–2)

2 (1–3)

0.023

Secondary outcomes

 Percentage of days with hypoxia, %

12 (0–31)

5 (0–20)

0.31

 Number of days with hypoxia

1 (0–3)

1 (0–2)

0.24

 Number of days under oxygen therapy

7 (3–13)

5 (2–17)

0.78

 ABG (number during follow-up)

14 (5–25)

10 (5–25)

0.82

 Duration of oxygen therapy (hours)

166(56–306)

111(40–396)

0.58

 Percentage of time (hours) with PaO2 ≥ 100 mmHg, %

7.4 (0–24.8)

17.3 (3.8–43.1)

0.0069

 Percentage of time (hours) with  PaO2 ≥ 120 mmHg, %

0 (0–7.2)

5.6 (0–18.1)

0.0037

 Mean daily PaO2, mmHg

84 ± 25

83 ± 28

0.36

 Mean FiO2/patient

0.32 (0.26–0.43)

0.36 (0.30–0.43)

0.07

 Hours of MV under an FiO2 = 0.21, hours

0(0–34)

0(0–8)

0.0036

 MV duration, days

6 (3–12)

4.5 (2–14)

0.45

 MV free days at day 28, days

19 (2–25)

19 (0–25)

0.82

 At least one atelectasis

22 (29)

18 (25)

0.59

 VAP

18 (24)

24 (34)

0.19

 ICU LOS, days

8 (4–17)

8 (5–17)

0.68

 ICU mortality

16 (21)

17 (24)

0.84

Values are median (Q1–Q3), mean ± SD or n (%)

H hyperoxia defined as a PaO2 ≥ 100 mmHg, h hypoxia defined as a PaO2 < 60 mmHg, ABG arterial blood gases, FiO2 fraction of inspired oxygen, PaO2 arterial partial pressure of oxygen, MV mechanical ventilation, VAP ventilator-associated pneumonia, ICU intensive care unit, LOS length of stay

*p < 0.0294 considered significant according to Pocock’s correction for intermediate analysis (see esm for methods)

The use of ORI monitoring to titrate oxygen rates allowed an important reduction of the time spent with hyperoxia compared with the use of SpO2 alone, probably because nurses are reluctant to decrease oxygen rates when SpO2 is in a normal range. A nurse-driven protocol to adjust FiO2 according to SpO2 was already in place in our unit, explaining why the percentage of time with hyperoxia we observed in the control group was much less than usually reported (30 vs 60%) [4]. This strategy to decrease oxygen rate according to ORI (which detects high PaO2) may thus be even more efficient in units where there is no protocol to adjust oxygen rates. SpO2 could remain a warning for hypoxia and ORI for hyperoxia. Larger studies are needed to evaluate the clinical benefit of this strategy.

Notes

Acknowledgements

The CHU d’Angers was the sponsor of the study. MASIMO provided the sensors at no cost, but was not involved in any aspect of the study.

Compliance with ethical standards

Conflicts of interest

SL received speaking fees from MASIMO. All the other authors declare that they have no conflict of interest.

Supplementary material

134_2019_5732_MOESM1_ESM.docx (273 kb)
Supplementary material 1 (DOCX 272 kb)

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Copyright information

© The Author(s) 2019

Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Authors and Affiliations

  1. 1.Département Anesthésie-RéanimationUBL Université d’Angers, CHU AngersAngers Cedex 9France

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