Driving Pressure and Postoperative Pulmonary Complications in Thoracic Surgery

NCT04260451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2021-07-12

No results posted yet for this study

Summary

Pulmonary complications are the most common complication in thoracic surgery and the leading cause of mortality.Therefore, lung protection is utmost important, and protective ventilation is strongly recommended in thoracic surgery. Protective ventilation is a prevailing ventilatory strategy in these days and is comprised of small tidal volume, limited inspiratory pressure, and application of positive end-expiratory pressure. However, several retrospective studies recently suggested that tidal volume, inspiratory pressure, and positive end-expiratory pressure are not related to patient outcomes, or only related when they influenced the driving pressure. Recently, the investigators reported the first prospective study about the driving pressure-guided ventilation in thoracic surgery. PEEP was titrated to bring the lowest driving pressure in each patient and applied throughout the one lung ventilation. The application of individualized PEEP reduced the incidence of pulmonary complications.However, that study was small size single center study with 312 patients. Thus, investigators try to perform large scale multicenter study. Through this study investigators evaluate that driving pressure-guided ventilation can reduce the incidence of postoperative pulmonary complications compared with conventional protective ventilation in thoracic surgery.

Conditions

  • One-Lung Ventilation
  • Postoperative Complications
  • Driving Pressure
  • Postoperative Pulmonary Complication
  • Thoracic Surgery
  • Positive End Expiratory Pressure

Interventions

OTHER

ventilation

Driving Pressure Limited Ventilation Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 10 to 2 cmH2O during one-lung ventilation. 1\. Lung recruitment: stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg, inspiratory:expiratory 1:1, respiratory rate 10. and driving pressure up to 20 cmH2O. Then decremental PEEP titration is performed using a volume-controlled ventilation until the lowest driving pressure (plateau pressure minus PEEP) is found. This individualized PEEP is adjusted during one-lung ventilation.

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER
  • Seoul National University Hospital

    collaborator OTHER
  • Asan Medical Center

    collaborator OTHER
  • Korea University Guro Hospital

    collaborator OTHER
  • The Catholic University of Korea

    collaborator OTHER
  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2021-04-15
Completion
2021-05-31

Countries

  • South Korea

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 NCT04260451 on ClinicalTrials.gov