NCT02158923

Individualized Perioperative Open Lung Ventilatory Strategy

Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 920 (actual)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.

Conditions

• Moderated-high Risk of Postoperative Pulmonary Complication
• Abdominal Surgery Expected More Than Two Hours

Interventions

Type	Name	Description
PROCEDURE	Alveolar recruitment maneuver	To start Alveolar Recruitment Maneuver (ARM), change ventilatory pressure-controlled mode (PCV) with 15 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 10 cmH2O. PEEP level will increase 5 on 5 cmH2O every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (25 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)
PROCEDURE	Calculation of optimal PEEP	Change ventilation mode to volume controlled ventilation (VCV) with a VT of 8 ml / kg, RR 15 rpm and adjust a PEEP of 20 cmH2O. Descend PEEP level 2 by 2 cmH2O every 30 seconds until obtain the best respiratory system compliance (Crs) PEEP. Once you know the optimal level of PEEP (best Crs PEEP), will be conducted again alveolar recruitment maneuver and adjust the best Crs level of PEEP + 2 cmH2O .
PROCEDURE	Postoperative CPAP	Postoperatively, non-invasive mechanical ventilation with a CPAP of 5 cmH2O (or 10 cmH2O if BMI\> 30) with a FiO2 of 0.5 will be applied.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-06-09
• Last updated: 2016-05-17

Locations

7 sites across 4 countries: United States, Argentina, Spain, Sweden