Individualized Perioperative Open Lung Ventilatory Strategy

Not Applicable

Completed

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

• Registration Number: NCT02158923
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-09
• Study Start: 2014-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-14
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 920

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 >35.
• 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.
• Participation in another experimental protocol at the time of intervention selection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Reduction of lung and systemic postoperative complications	Up to 7 postoperative days

Secondary Outcome Measures

Name	Time	Method
Reduction of lung and systemic postoperative complications	Up to 30 postoperative days

Trial Locations

Locations (7)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Hospital Privado de la Comunidad; 🇦🇷 Mar de Plata, Buenos Aires, Argentina

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Department of Anesthesia and Critical Care; Hospital Clinico Universitario; 🇪🇸 Valencia, Spain

Uppsala University Hospital; 🇸🇪 Uppsala, Uppland, Sweden