Individualized Perioperative Open Lung Ventilatory Strategy

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT02158923

Run by

Fundación para la Investigación del Hospital Clínico de Valencia

People needed

920

Starts

2014-09-01

Expected to finish

2016-04-01

Last updated by the study team

2016-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Hospital Privado de la Comunidad — Mar del Plata, Buenos Aires, Argentina
• Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain
• Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain
• Hospital Gregorio Marañón — Madrid, Madrid, Spain
• Department of Anesthesia and Critical Care; Hospital Clinico Universitario — Valencia, Valencia, Spain
• Uppsala University Hospital — Uppsala, Uppland, Sweden

Full record on ClinicalTrials.gov

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