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

Fundación para la Investigación del Hospital Clínico de Valencia7 sites in 4 countries920 target enrollmentSeptember 2014

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Moderated-high Risk of Postoperative Pulmonary Complication
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Enrollment: 920
Locations: 7
Primary Endpoint: Reduction of lung and systemic postoperative complications
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Responsible Party

Principal Investigator

Carlos Ferrando

MD, PhD

Fundación para la Investigación del Hospital Clínico de Valencia

Eligibility Criteria

Inclusion Criteria

•Age not less than 18
•Risk of postoperative pulmonary complication moderate-high defined by a score ≥ 26 on the risk scale ARISCAT (based on the analysis of seven factors, where a score between 26 and 44 points defines a moderate risk, and a score\> 44 points define a high risk, included in the Information Booklet Investigator).
•Planned abdominal surgery\> 2 hours.
•Signed informed consent for participation in the study.

Exclusion Criteria

•Age less than 18 years.
•Pregnant or breast-feeding.
•Patients with BMI \>
•Syndrome of moderate or severe respiratory distress: PaO2/FiO2 \< 200 mmHg.
•Heart failure: NYHA IV.
•Hemodynamic failure: CI \<2.5 L/min/m2 and / or requirements before surgery ionotropic support.
•Diagnosis or suspicion of intracranial hypertension (intracranial pressure\> 15 mmHg).
•Mechanical ventilation in the last 15 days.
•Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
•Patient with preoperatively CPAP.