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Running title: NAVA may reduce weaning duration from mechanical ventilation

Running title: NAVA may reduce weaning duration from mechanical ventilation. A randomized controlled trial to compare Neurally adjusted ventilatory assist versus pressure support ventilation in patients difficult to wean from mechanical ventilation.

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Running title: NAVA may reduce weaning duration from mechanical ventilation

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  1. Running title: NAVA may reduce weaning duration from mechanical ventilation A randomized controlled trial to compare Neurally adjusted ventilatory assist versus pressure support ventilation in patients difficult to wean from mechanical ventilation Ling Liu1, Xiaoting Xu1, Qin Sun1, Yue Yu1, Feiping Xia1, Jianfeng Xie1, Yi Yang1, Leo Heunks2*, Haibo Qiu1* Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, Jiangsu, China 2Amsterdam UMC, location VUmc, Amsterdam, the Netherlands *Joint corresponding authors

  2. Study designs • Prospective Randomized controlled trial • One general ICU, From October 2011 to September 2017 • Clinicaltrials.gov (NCT01280773) • The protocol was approved by Institutional Ethics Committee of Zhongda hospital (Approval Number: 2010ZDLL018.0) Patient • Patients receiving acute invasive mechanical ventilation for more than 24h were eligible when meeting all the following criteria Failing the initial spontaneous breathing trial (SBT) or re-intubated within 48 h after the first extubation able to sustain PSV more than 1h with inspiratory support ≤ 15 cmH2O, hemodynamic stable (heart rate < 140 beats/min, no vasopressors required or ≤ 5 μg.kg-1.min-1 dopamine/ dobutamine, or ≤ 0.2 μg.kg-1.min-1norepinephrine), Maintain light sedation (RASS ≥ -2) during day time

  3. Hypothesis We reasoned that a ventilator mode that improves patient ventilator interaction and delivers proportional support most likely improves weaning outcome in patients difficult to wean from mechanical ventilation. Ventilation strategies • PSV • support level was set to obtain a Vt of 6–8 ml/kg. PBW • flow-trigger- 1 L/min • cycle off -30 % • NAVA • NAVA level was titrated to obtain a Vt of 6–8 ml/kg. PBW • EAdi trigger-0.5 μV • cycles off -70 % of peak EAdi • FiO2 and PEEP were set by the physician in charge to maintain the SpO2 ≥ 90%

  4. Materials and methods Weaning protocol Daily screen at 9:00 AM Patients were screened once daily for possible SBT from the first day after randomization (day 1) A 30-minute SBT CPAP of 5 cm H2O or PSV with inspiratory pressure of 7 cmH2O and 5 cmH2O of PEEP Success Failed Reconnected and ventilated in either NAVA or PSV mode No Adequate cough Restore to ventilation settings before SBT Yes Decisions related to tracheostomy, post-extubation NIV and reintubation were made by clinical team. Extubation

  5. Primary outcome • The percentage of patients who were never weaned from mechanical ventilation was 17% (8/47) in NAVA group and 33% (17/52) in PSV group (P = 0.073)

  6. Secondary outcomes Conclusions In patients who were difficult to wean, NAVA decreased duration of weaning and increase ventilator-free days. NAVA which improved patient-ventilator asynchrony, is safe, feasible and effective during weaning.

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