NCT03182062

Individualized Perioperative Open-Lung Ventilatory Strategy During One-Lung Ventilation

Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation During One-lung Ventilation: A Prospective, Multicenter, Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• 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 during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and individually indicated ventilatory support will decrease postoperative pulmonary complications, ICU and hospital length of stay compared to a standardized Lung Protective Ventilation (LPV).

Conditions

• Thoraric Surgery
• Surgery Time Expected More Than Two Hours

Interventions

Type	Name	Description
PROCEDURE	Alveolar recruitment maneuver	To start the Alveolar Recruitment Maneuver (ARM) the ventilatory mode will be changed to pressure-controlled mode (PCV) with 20 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 5 cmH2O. The PEEP level will be increased in 5 cmH2O steps every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (20 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)
PROCEDURE	PEEP Titration Trial	The ventilation mode will then switch back to volume controlled ventilation with the same baseline settings but with 20 cmH2O PEEP level. Then PEEP will be reduced in 2 cmH2O steps each maintained for 5 breaths the level of PEEP with the best (higher) dynamic compliance.
PROCEDURE	Lung protective ventilation	Ventilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial.

Timeline

• Start date: 2018-09-08
• Primary completion: 2020-01-01
• Completion: 2020-07-01
• First posted: 2017-06-09
• Last updated: 2018-10-03

Locations

4 sites across 1 country: Spain