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Randomized Controlled Trial
. 2021 Oct:65:274-281.
doi: 10.1016/j.jcrc.2021.06.017. Epub 2021 Jul 5.

Evolution of practice patterns in the management of acute respiratory distress syndrome: A secondary analysis of two successive randomized controlled trials

Kate C Tatham  1 , Niall D Ferguson  2 , Qi Zhou  3 , Lori Hand  3 , Peggy Austin  3 , Ravi Taneja  4 , Alejandro C Arroliga  5 , Juan F Sanchez  5 , Edgar J Jimenez  5 , Brandon P Staub  6 , Michelle E Kho  7 , J Guillermo Domínguez-Cherit  8 , Adam Mullaly  9 , Yaseen M Arabi  10 , Maureen O Meade  11
Affiliations
Randomized Controlled Trial

Evolution of practice patterns in the management of acute respiratory distress syndrome: A secondary analysis of two successive randomized controlled trials

Kate C Tatham et al. J Crit Care. 2021 Oct.

Abstract

Purpose: We sought to examine changes in acute respiratory distress syndrome (ARDS) management over a 12-year period of two successive randomized trials.

Methods: Analyses included baseline data, from eligible patients, prior to influence of trial protocols, and daily study data, from randomized patients, of variables not determined by trial protocols. Mixed linear regressions examined changes in practice year-on-year.

Results: A total of 2376 patients met the inclusion criteria. Over the 12-year period, baseline tidal volume index decreased (9.0 to 7.0 ml/kg, p < 0.001), plateau pressures decreased (30.8 to 29.0 cmH2O, p < 0.05), and baseline positive end-expiratory pressures increased (10.8 to 13.2 cmH2O, p < 0.001). Volume-controlled ventilation declined from 29.4 to 14.0% (p < 0.01). Use of corticosteroids increased (baseline: 7.7 to 30.3%; on study: 32.6 to 61.2%; both p < 0.001), as did neuromuscular blockade (baseline: 12.3 to 24.5%; on study: 55.5 to 70.0%; both p < 0.01). Inhaled nitric oxide use increased (24.9 to 65.8%, p < 0.05). We observed no significant change in prone positioning (16.2 to 18.9%, p = 0.70).

Conclusions: Clear trends were apparent in tidal volume, airway pressures, ventilator modes, adjuncts and rescue therapies. With the exception of prone positioning, and outside the context of rescue therapy, these trends appear consistent with the evolving literature on ARDS management.

Keywords: ARDS; Corticosteroid; High frequency oscillatory ventilation; Inhaled nitric oxide; Mechanical ventilation; Neuromuscular blockade; PEEP; Plateau pressure; Tidal volume; Volume-controlled ventilation.

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Conflict of interest statement

Declaration of Competing Interest All the other authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
Trends in ventilation parameters (VT, PPlat and PEEP): Protective lung ventilation strategies have increased over time. A significant drop in mean VT index (p < 0.001, n = 1272) and PPlat (p < 0.05, total n = 1090) at the point of trial eligibility was observed over the 12-year study period (Fig. 1A, B). Conversely mean PEEP values (1C) exhibited a significant increase over time (p < 0.001, n = 1509), which may be attributable to the large studies published concomitantly in the years indicated (i. 2004: ‘ALVEOLI’ [20], ii. 2008: ‘LOVS’ [17] and ‘ExPress’ [21], iii. 2010: Briel et al. [5]). (Adjusted data shown; raw data: VTp < 0.001; PPlatp < 0.01; PEEP p < 0.001.)
Fig. 2
Fig. 2
Trends in ventilation modes: Volume-controlled ventilation use has declined over time. A significant drop in the use of volume-controlled ventilation (2A) was observed over the study period (p < 0.01, n = 1495). No such pattern was seen in the use of pressure-controlled and pressure support ventilation (2B–C). (Adjusted data shown; raw data: all modes - not significant (NS).)
Fig. 3
Fig. 3
Trends in adjuncts: Pharmacological interventions (corticosteroids and NMBDs) increased in use over time, whereas PAC use declined. A significant increase in corticosteroid use was observed at baseline (Fig. 3A, p < 0.001, n = 1805) and over the study period (Fig. 3B, p < 0.001, n = 1094). Timing of relevant concomitant trials is indicated; i. 2006 Steinberg et al. [12] and ii. 2008: ‘CORTICUS’ [19]. A similar pattern was observed with the use of NMBDs at baseline (Fig. 3C, p < 0.01, n = 1805) and on study (Fig. 3D, p < 0.01, n = 1093). The timing of the ‘ACURASYS’ trial (2010) is shown (iii) [15]. The use of the PACs was observed to trend downwards at baseline and over the same period at baseline (Fig. 3E, p < 0.01, n = 1805) and on study (Fig. 3F, p < 0.01, n = 1093). (Adjusted data shown; raw data: p values all <0.01).
Fig. 4
Fig. 4
Trends in rescue therapy use: Adoption of iNO and HFOV increased over time. The use of iNO demonstrated a significant increase over the twelve years (Fig. 4A, p < 0.05, n = 261), despite the negative findings reported on its use, in a systematic review during the study period by Adhikari et al. in 2007 (i). [26] HFOV use also increased significantly over the study period (Fig. 4B, p < 0.05, n = 263), as a rescue therapy for ARDS, coinciding with publication of a large meta-analysis and systematic review in 2010 (ii) [27]. (Adjusted data shown; raw data: p < 0.01 for both). No significant trend was exhibited with the use of prone positioning before or after adjustment (Fig. 4C, p = non-significant (NS), n = 261).
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