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. 2023 Dec 29;13(1):209.
doi: 10.3390/jcm13010209.

Safety and Feasibility of Intraoperative High PEEP Titrated to the Lowest Driving Pressure (ΔP)-Interim Analysis of DESIGNATION

Sunny G L H Nijbroek  1   2 , Liselotte Hol  1 , Ary Serpa Neto  3   4 , David M P van Meenen  1 , Sabrine N T Hemmes  5 , Markus W Hollmann  1 , Marcus J Schultz  3   6   7 ; DESIGNATION Investigators
Affiliations

Safety and Feasibility of Intraoperative High PEEP Titrated to the Lowest Driving Pressure (ΔP)-Interim Analysis of DESIGNATION

Sunny G L H Nijbroek et al. J Clin Med. .

Abstract

Uncertainty remains about the best level of intraoperative positive end-expiratory pressure (PEEP). An ongoing RCT ('DESIGNATION') compares an 'individualized high PEEP' strategy ('iPEEP')-titrated to the lowest driving pressure (ΔP) with recruitment maneuvers (RM), with a 'standard low PEEP' strategy ('low PEEP')-using 5 cm H2O without RMs with respect to the incidence of postoperative pulmonary complications. This report is an interim analysis of safety and feasibility. From September 2018 to July 2022, we enrolled 743 patients. Data of 698 patients were available for this analysis. Hypotension occurred more often in 'iPEEP' vs. 'low PEEP' (54.7 vs. 44.1%; RR, 1.24 (95% CI 1.07 to 1.44); p < 0.01). Investigators were compliant with the study protocol 285/344 patients (82.8%) in 'iPEEP', and 345/354 patients (97.5%) in 'low PEEP' (p < 0.01). Most frequent protocol violation was missing the final RM at the end of anesthesia before extubation; PEEP titration was performed in 99.4 vs. 0%; PEEP was set correctly in 89.8 vs. 98.9%. Compared to 'low PEEP', the 'iPEEP' group was ventilated with higher PEEP (10.0 (8.0-12.0) vs. 5.0 (5.0-5.0) cm H2O; p < 0.01). Thus, in patients undergoing general anesthesia for open abdominal surgery, an individualized high PEEP ventilation strategy is associated with hypotension. The protocol is feasible and results in clear contrast in PEEP. DESIGNATION is expected to finish in late 2023.

Keywords: PEEP; RM; anesthesia; driving pressure; feasibility; interim analysis; intraoperative ventilation; positive end–expiratory pressure; recruitment maneuver; safety; ventilation.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(A) Patients allocated to the ‘individualized high PEEP’ group receive a first recruitment maneuver (RM) followed by a decremental PEEP titration and a second RM. The RMs are performed with the ventilator in a volume-controlled ventilation modus and with the respiratory rate set at 15 breaths per minute. An inspiratory pause is manually set at 30%. Every 15 s, PEEP is incrementally increased from 5 cm H2O with steps of 5 cm H2O up to 20 cm H2O. The decremental PEEP titration starts at the end of the first RM at PEEP 20 cm H2O, with ventilator in a volume-controlled ventilation modus, and with the respiratory rate set at 15 breaths per minute. In steps of 20 s, PEEP is stepwise decreased steps of 2 cm H2O for 20 s until a minimum level of 6 cm H2O is reached. At the end of each step, the resulting ΔP is calculated by subtracting PEEP from the plateau pressure. A second RM follows the decremental PEEP titration, after which PEEP is set and kept at the highest level where ΔP was lowest. (B) A bedside ‘ΔP–PEEP’ graph is to be constructed by plotting the ΔP against PEEP using the empty chart. (C) From this ‘ΔP–PEEP’ graph, we can visually observe a nadir in ΔP, and identify the highest level of PEEP with the lowest ΔP (represented in subpanels (a–d) with the arrow). If no nadir in ΔP is present in the ΔP–PEEP graph (represented in subpanels (e,f)), we use a PEEP level of 12 cm H2O.
Figure 2
Figure 2
CONSORT flow diagram.
Figure 3
Figure 3
PEEP, Plateau pressure, Peak pressure, Respiratory Rate over time according to groups.
Figure 4
Figure 4
ΔP over time according to groups. ΔP, Driving pressure.
Figure 5
Figure 5
Cumulative distribution of PEEP at different time points during surgery between groups.
Figure 6
Figure 6
Cumulative distribution of ΔP at different time points during surgery between groups. ΔP, Driving pressure.
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