Table 2.
Outcomes among patients treated with driving pressure-limiting strategy vs low PEEP strategy. CI, confidence interval; ECMO, extracorporeal membrane oxygenation; IQR, interquartile range; MD, mean difference; OR, odds ratio; ORp, proportional odds ratio; PEEP, positive end-expiratory pressure. ∗ORp from ordinal model adjusted for age, COVID-19 diagnosis, baseline ventilatory rate, and PEEP at randomisation. †MD: zero-inflated beta-binomial model adjusted for age, COVID-19 diagnosis, baseline ventilatory rate, and PEEP at randomisation. ‡OR: logistic mixed-effects model adjusted for age, COVID-19 diagnosis, baseline ventilatory rate, and PEEP at randomisation. ¶One patient from the low PEEP group underwent this rescue therapy three times; two patients from the low PEEP group and one patient from the intervention group were subjected to this rescue therapy twice. §MD: generalised linear mixed-effects model with Gamma distribution adjusted for age, COVID-19 diagnosis, baseline ventilatory rate, and PEEP at randomisation.
| Outcome | Driving pressure-limitingwith PEEP titrationgroup (n=96) | Low PEEPgroup(n=102) | Effectestimate | Effect estimate(95% CI) | P-value |
|---|---|---|---|---|---|
| Primary outcome | |||||
| Ventilator-free days in 28 days | |||||
| Mean (sd) | 6 (9) | 7 (9) | ORp∗ | 0.72 (0.39–1.32) | 0.28 |
| MD† | –1.28 (–3.60 to 1.26) | ||||
| Median (IQR) | 0 (0–15) | 0 (0–17) | |||
| Secondary outcomes | |||||
| Death, n events/n total (%) | |||||
| In the intensive care unit | 63/96 (66) | 54/102 (53) | OR‡ | 1.66 (0.87–3.17) | 0.13 |
| In the hospital | 63/96 (66) | 56/102 (55) | OR | 1.48 (0.77–2.85) | 0.24 |
| Rescue therapies, n (%) | |||||
| ECMO | 0/96 (0) | 0/102 (0) | – | – | – |
| Recruitment manoeuvre(outside protocol)¶ | 2/96 (2) | 4/102 (4) | OR | 0.52 (0.09–3.13) | 0.48 |
| Inhaled nitric oxide | 1/96 (1) | 1/102 (1) | OR | 1.09 (0.04–27.13) | 0.96 |
| Safety outcome | |||||
| Barotrauma, n (%) | 4/96 (4) | 3/102 (3) | OR | 1.35 (0.28–6.55) | 0.71 |
| Tertiary outcomes | |||||
| Length of stay (days) | |||||
| In the intensive care unit | |||||
| Mean (sd) | 17 (16) | 17 (15) | MD§ | –0.71 (–4.11 to 2.69) | 0.68 |
| Median (IQR) | 12 (7–21) | 14 (8–22) | |||
| In the hospital | |||||
| Mean (sd) | 20 (19) | 22 (18) | MD | –2 (–6.22 to 2.23) | 0.35 |
| Median (IQR) | 16 (8–25) | 18 (10–28) | |||
| ICU-free days in 28 days | |||||
| Mean (sd) | 4 (8) | 5 (8) | MD | 0.72 (0.39–1.32) | 0.39 |
| Median (IQR) | 0 (0–10) | 0 (0–12) | |||