Individualized Perioperative Open Lung Ventilatory Strategy

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

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.

Sponsors & Collaborators

• Hospital de Manises

  collaborator OTHER

• Hospital General Valencia

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Hospital de Sant Pau

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Hospital General Universitario de Alicante

  collaborator OTHER

• Hospital Juan Canalejo

  collaborator OTHER

• Hospital General Regional de León

  collaborator OTHER_GOV

• Hospital Universitario Virgen de la Arrixaca

  collaborator OTHER

• Hospital Miguel Servet

  collaborator OTHER

• Hospital Clínico Universitario de Valladolid

  collaborator OTHER

• Hospital Universitario Fundación Alcorcón

  collaborator OTHER

• Hospital General de Ciudad Real

  collaborator OTHER

• Hospital Universitario de Valme

  collaborator OTHER

• Hospital de Basurto

  collaborator OTHER

• Hospital Dr. Negrín

  collaborator UNKNOWN

• Hospital de Galdakano

  collaborator UNKNOWN

• Complejo Hospitalario de Especialidades Juan Ramón Jimenez

  collaborator OTHER

• Puerta de Hierro University Hospital

  collaborator OTHER

• Fundación para la Investigación del Hospital Clínico de Valencia

  lead OTHER

Principal Investigators

• Carlos Ferrando, MD, PhD · Hospital Clínico Universitario Valencia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• United States
• Argentina
• Spain
• Sweden

Study Locations