A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery

Background: Intraoperative fluid therapy guided by mechanical ventilation-induced pulse-pressure variation (PPV) may improve outcomes after major surgery. We tested this hypothesis in a multi-center study. Methods: The patients were included in two periods: a first control period (control groupn = 147) in which intraoperative fluids were given according to clinical judgment. After a training period, intraoperative fluid management was titrated to maintain PPV < 10% in 109 surgical patients (PPV group). We performed 1:1 propensity score matching to ensure the groups were comparable with regard to age, weight, duration of surgery, and type of operation. The primary endpoint was postoperative hospital length of stay. Results: After matching, 84 patients remained in each group. Baseline characteristics, surgical procedure duration and physiological parameters evaluated at the start of surgery were similar between the groups. The volume of crystalloids (4500 mL [3200-6500 mL] versus 5000 mL [3750-8862 mL]P = 0.01), the number of blood units infused during the surgery (1.7 U [0.9-2.0 U] versus 2.0 U [1.7-2.6 U]P = 0.01), the fraction of patients transfused (13.1% versus 32.1%P = 0.003) and the number of patients receiving mechanical ventilation at 24 h (3.2% versus 9.7%P = 0.027) were smaller postoperatively in PPV group. Intraoperative PPV-based improved the composite outcome of postoperative complications OR 0.59 [95% CI 0.35-0.99] and reduced the postoperative hospital length of stay (8 days [6-14 days] versus 11 days [7-18 days]P = 0.01). Conclusions: In high-risk surgeries, PPV-directed volume loading improved postoperative outcomes and decreased the postoperative hospital length of stay.DIXTAL BIOMEDICA INDUSTRIA E COMERCIO LIDAUniv Sao Paulo, Fac Med, Hosp Clin, Div Anestesia, Av Eneas Carvalho de Aguiar,255 2 Andar, BR-05403900 Sao Paulo, SP, BrazilHosp Padre Albino, Catanduva Med Sch, Catanduva, SP, BrazilUniv Fed Sao Paulo, Hosp Sao Paulo, Sao Paulo, SP, BrazilUniv Fed Sao Paulo, Hosp Sao Paulo, Sao Paulo, SP, BrazilWeb of Scienc

Effect of lung recruitment and titrated Positive End-Expiratory Pressure (PEEP) vs low PEEP on mortality in patients with acute respiratory distress syndrome - A randomized clinical trial

IMPORTANCE: The effects of recruitment maneuvers and positive end-expiratory pressure (PEEP) titration on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remain uncertain. OBJECTIVE: To determine if lung recruitment associated with PEEP titration according to the best respiratory-system compliance decreases 28-day mortality of patients with moderate to severe ARDS compared with a conventional low-PEEP strategy. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized trial conducted at 120 intensive care units (ICUs) from 9 countries from November 17, 2011, through April 25, 2017, enrolling adults with moderate to severe ARDS. INTERVENTIONS: An experimental strategy with a lung recruitment maneuver and PEEP titration according to the best respiratory-system compliance (n = 501; experimental group) or a control strategy of low PEEP (n = 509). All patients received volume-assist control mode until weaning. MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality until 28 days. Secondary outcomes were length of ICU and hospital stay; ventilator-free days through day 28; pneumothorax requiring drainage within 7 days; barotrauma within 7 days; and ICU, in-hospital, and 6-month mortality. RESULTS: A total of 1010 patients (37.5% female; mean [SD] age, 50.9 [17.4] years) were enrolled and followed up. At 28 days, 277 of 501 patients (55.3%) in the experimental group and 251 of 509 patients (49.3%) in the control group had died (hazard ratio [HR], 1.20; 95% CI, 1.01 to 1.42; P = .041). Compared with the control group, the experimental group strategy increased 6-month mortality (65.3% vs 59.9%; HR, 1.18; 95% CI, 1.01 to 1.38; P = .04), decreased the number of mean ventilator-free days (5.3 vs 6.4; difference, −1.1; 95% CI, −2.1 to −0.1; P = .03), increased the risk of pneumothorax requiring drainage (3.2% vs 1.2%; difference, 2.0%; 95% CI, 0.0% to 4.0%; P = .03), and the risk of barotrauma (5.6% vs 1.6%; difference, 4.0%; 95% CI, 1.5% to 6.5%; P = .001). There were no significant differences in the length of ICU stay, length of hospital stay, ICU mortality, and in-hospital mortality. CONCLUSIONS AND RELEVANCE: In patients with moderate to severe ARDS, a strategy with lung recruitment and titrated PEEP compared with low PEEP increased 28-day all-cause mortality. These findings do not support the routine use of lung recruitment maneuver and PEEP titration in these patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01374022