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Open Lung PEEP in Thoracic Surgery

Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia (Other)
Overall Status
Completed
CT.gov ID
NCT03184974
Collaborator
(none)
690
Enrollment
13
Actual Duration (Months)

Study Details

Study Description

Brief Summary

During thoracic surgical procedures, while ventilating with a protective tidal volume, an open lung approach consisting of a recruitment maneuver followed by an individualized positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance (Open-lung PEEP, OL-PEEP) would decrease driving pressure. To test this hypothesis, we performed a multicenter observational study in 17 Spanish teaching hospitals of patients undergoing one lung ventilation (OLV). In addition, we analyzed the association between the driving pressure and the prevalence of postoperative pulmonary complications (PPCs), and finally the association between the individualized PEEP and relevant patient preoperative or intraoperative variables.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    690 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Individualized Open Lung PEEP in Thoracic Surgery: A Prospective Multicenter Observational Study in 17 Spanish Hospitals
    Actual Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Oct 1, 2016
    Actual Study Completion Date :
    Nov 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative pulmonary complications [Postoperative. One week]

      Atelectasis, acute respiratory failure, ARDS, pneumonia, reintubation, empyema, bronchospasm, pneumothorax, pneumonitis, bronchopleural fistula

    Secondary Outcome Measures

    1. Descriptive analysis of the open lung PEEP [intraoperative]

      Open lung PEEP is the PEEP of best dynamic respiratory system compliance during a PEEP titration trial

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing one lung ventilation
    Exclusion Criteria:
    • No exclusion criteria

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fundación para la Investigación del Hospital Clínico de Valencia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carlos Ferrando, Principal investigador, Fundación para la Investigación del Hospital Clínico de Valencia
    ClinicalTrials.gov Identifier:
    NCT03184974
    Other Study ID Numbers:
    • PEEPOPTIMA
    First Posted:
    Jun 14, 2017
    Last Update Posted:
    Mar 7, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aneurysm, Dissecting

    Study Results

    No Results Posted as of Mar 7, 2018