PReVENT - protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial

Simonis, Fabienne D.; Binnekade, Jan M.; Braber, Annemarije; Gelissen, Harry P.; Heidt, Jeroen; Horn, Janneke; Innemee, Gerard; de Jonge, Evert; Juffermans, Nicole P.; Spronk, Peter E.; Steuten, Lotte M.; Tuinman, Pieter Roel; Vriends, Marijn; de Vreede, Gwendolyn; de Wilde, Rob B.; Serpa Neto, Ary; Gama de Abreu, Marcelo; Pelosi, Paolo; Schultz, Marcus J.

doi:10.1186/s13063-015-0759-1

Trials

Table 1 Ventilator settings with the two ventilation strategies

From: PReVENT - protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial

	Lower tidal volume ventilation	Higher tidal volume ventilation
Ventilator mode	Assisted MV = volume- controlled	Assisted MV = volume-controlled
Ventilator mode	Spontaneous MV = pressure support	Spontaneous MV = pressure support
Target tidal volume	4 ml/kg PBW	10 ml/kg PBW
Allowable tidal volume in case of high pressures (in the high tidal group) or severe dyspnea (in the low tidal group)	6 ml/kg PBW^a	8 ml/kg PBW^a
Allowable ventilator rate setting needed to achieve normal pH (7.25 to 7.45)	6 to 35 breaths/minute; typically higher than with an higher tidal volume	6 to 35 breaths/minute; typically lower than with a lower tidal volume
Inspiration-to-expiration ratio	1:2	1:2
PaO₂ or SpO_2-targets	7.3 to 10.7 kPa (55 to 80 mmHg), or 90 to 92 %	7.3 to 10.7 kPa (55 to 80 mmHg), or 90 to 92 %
Allowable combinations of FiO₂ and PEEP	0.21 and 5 cmH₂O	0.21 and 5 cmH₂O
	0.30 and 5 cmH₂O	0.30 and 5 cmH₂O
	0.40 and 5 cmH₂O	0.40 and 5 cmH₂O
	0.40 and 8 cmH₂O	0.40 and 8 cmH₂O
	0.50 and 8 cmH₂O	0.50 and 8 cmH₂O
	0.50 and 10 cmH₂O	0.50 and 10 cmH₂O
	0.60 and 10 cmH₂O	0.60 and 10 cmH₂O
Daily assessment of the ability to breathe with pressure support	Required when FiO₂ ≤ 0.4 or earlier	Required when FiO₂ ≤ 0.4 or earlier
Allowable tidal volume when ARDS develops	6 ml/kg PBW	6 ml/kg PBW
Allowable tidal volume when ARDS develops; in case of severe dyspnea or unacceptable pH	8 ml/kg PBW	8 ml/kg PBW
Allowable combinations of FiO₂ and PEEP (continued)	0.21 and 5 cmH₂O	0.21 and 5 cmH₂O
	0.30 and 5 cmH₂O	0.30 and 5 cmH₂O
	0.40 and 5 cmH₂O	0.40 and 5 cmH₂O
	0.40 and 8 cmH₂O	0.40 and 8 cmH₂O
	0.50 and 8 cmH₂O	0.50 and 8 cmH₂O
	0.50 and 10 cmH₂O	0.50 and 10 cmH₂O
	0.60 and 10 cmH₂O	0.60 and 10 cmH₂O
	0.70 and 10 cmH₂O	0.70 and 10 cmH₂O
	0.70 and 12 cmH₂O	0.70 and 12 cmH₂O
	0.70 and 14 cmH₂O	0.70 and 14 cmH₂O
	0.80 and 14 cmH₂O	0.80 and 14 cmH₂O
	0.90 and 14 cmH₂O	0.90 and 14 cmH₂O
	0.90 and 16 cmH₂O	0.90 and 16 cmH₂O
	0.90 and 18 cmH₂O	0.90 and 18 cmH₂O
	1 and 18 cmH₂O	1 and 18 cmH₂O
	1 and 20 cmH₂O	1 and 20 cmH₂O
	1 and 22 cmH₂O	1 and 22 cmH₂O
	1 and 24 cmH₂O	1 and 24 cmH₂O

^awith pressure support tidal volumes could be higher than targeted with the lowest possible pressure support level, or lower than targeted with the highest allowed maximum airway pressure - this is accepted and never a reason for use of (more) sedation, paralytic agents, and/or switch to a controlled mode of ventilation
ARDS acute respiratory distress syndrome, FiO₂ O₂–fraction of inspired air, MV mechanical ventilation, PBW predicted body weight, PEEP positive end-expiratory pressure, SpO₂ peripheral O₂ saturation

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