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Intraoperative PEEP Optimization: Effects on Postoperative Pulmonary Complications and Inflammatory Response

NCT02931409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-02

No results posted yet for this study

Summary

The purpose of this prospective randomized controlled trial is to determine the effects of intraoperative lung protective mechanical ventilation using an individual optimal PEEP value on postoperative pulmonary complications and inflammatory response. A total number of 40 patients undergoing open radical cystectomy and urinary diversion will be enrolled and randomized into two groups. Standard lung protective ventilation using a PEEP of 6 cmH2O will be performed in control group and an optimal PEEP value determined during a static pulmonary compliance (Cstat) directed PEEP titration procedure will be applyed in study group. Low tidal volumes (6mL/Kg IBW) and a fraction of inspired oxygen (FiO2) of 0.5 will be applyed in both groups. Procalcitonin kinetics will be monitored during and after surgery until the third postoperative day as well as postoperative pulmonary complications. Clinical condition and extrapulmonary complications will be evaluated by the Sequential Organ Failure Assessment (SOFA) Score and in-hospital stay, 28-days and in-hospital mortality will also be followed.

Conditions

  • Pulmonary Complications
  • Inflammatory Response

Interventions

PROCEDURE

Optimal PEEP

Optimal PEEP determined by Cstat during PEEP titration procedure.

PROCEDURE

Standard PEEP

Lung protective mechanical ventilation applying a PEEP value of 6 cmH2O

Sponsors & Collaborators

  • Szeged University

    collaborator OTHER

  • Péterfy Sándor Hospital

    lead OTHER

Principal Investigators

  • Zsolt Molnár, Prof, MD, PhD, DEAA · University of Szeged, Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy

  • Zoltán Ruszkai, MD · Péterfy Sándor Hospital, Department of Anaesthesiology and Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931409 on ClinicalTrials.gov