Prone positioning and high-frequency oscillatory…

Findings

Between May 1, 2019 and Jan 13, 2026, 1045 patients were eligible for enrolment. The trial was stopped early for futility and slow enrolment after 424 of 600 planned patients were recruited. 126 patients were randomly assigned to the supine and conventional mechanical ventilation group, 130 to the prone and conventional mechanical ventilation group, 90 to the supine and HFOV group, and 78 to the prone and HFOV group. Median age was 3·3 years (IQR 1·1-10·1), 211 (50%) patients were female, and 213 (50%) were male. There were no significant differences in ventilator-free days between prone and supine positioning (median 17·9 days [IQR 8·9-21·3] vs 17·4 days [6·4-21·9]; Hodges-Lehmann location shift adjusting for ventilation 0·0 [95% CI -0·8 to 1·0]) or between HFOV and conventional mechanical ventilation (17·3 [5·7-21·6] vs 18·0 [9·9-21·5]; Hodges-Lehmann location shift adjusting for positioning -0·3 [95% CI -1·5 to 0·5]). 41 (10%) patients had died at day 28, without group differences. Plugging or obstruction of the artificial airway occurred more frequently with prone than supine positioning (14 events in 12 [6%] of 188 patients vs three events in three [2%] of 197 patients; 0·74 [95% CI 0·44-1·26] vs 0·15 [0·05-0·47] events per 100 artificial airway days; rate ratio 4·83 [95% CI 1·38-16·82]). Stage 2 or worse immobility-related pressure injuries also occurred more frequently with prone versus supine positioning (12 [6%] vs two [1%]; relative risk 6·13 [95% CI 1·45-25·97]). Haemodynamic instability occurred more frequently with HFOV than conventional mechanical ventilation (41 events in 19 [13%] of 141 patients vs 38 events in 22 [9%] of 244 patients; 2·21 [95% CI 1·63-3·00] vs 1·22 [0·89-1·68] events per 100 paediatric intensive care unit days; rate ratio 1·84 [95% CI 1·18-2·87]). One serious adverse event, an unwitnessed self-extubation followed by cardiopulmonary arrest, occurred in a patient in the prone and conventional mechanical ventilation group.

Prone positioning and high-frequency oscillatory ventilation in early paediatric acute respiratory distress syndrome (PROSpect): an international, two-by-two factorial, response-adaptive, phase 3, randomised controlled trial

Abstract

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