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The Open Lung Approach During One Lung Ventilation in Thoracic Surgery

Primary Purpose

Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Recruitment maneuver
Sponsored by
University of Foggia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18 years,
  • surgery and OLV lasting ≥ 60 min

Exclusion Criteria:

  • lung reduction surgery, pneumonectomy, patients with severe COPD with preoperative forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) ratio, expressed as a percentage (FEV1/FVC%) <60%, presence of large bullae, pleural diseases and/or acute or chronic uncompensated cardiac disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Open lung approach

    Arm Description

    Recruitment maneuver during OLV in thoracic surgery

    Outcomes

    Primary Outcome Measures

    Change in respiratory mechanics before and after the open lung approach
    Respiratory mechanics parameters were recorded, digitized and collected on a personal computer through a 12-bit analog-to digital converter board (DAQCard 700; National Instrument, Austin, TX) at a sample rate of 200 Hz (ICU Lab, KleisTEK Engineering, Bari, Italy).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2018
    Last Updated
    February 14, 2018
    Sponsor
    University of Foggia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03435523
    Brief Title
    The Open Lung Approach During One Lung Ventilation in Thoracic Surgery
    Official Title
    Optimal PEEP Based on the Open Lung Approach During One Lung Ventilation in Thoracic Surgery: a Physiological Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2012 (Actual)
    Primary Completion Date
    November 30, 2012 (Actual)
    Study Completion Date
    November 30, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Foggia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Question: Ventilatory strategy to counterbalance the effect of one lung ventilation during thoracic surgery. Findings: the open lung approach improved oxygenation and lung compliance, reducing respiratory system driving pressure and transpulmonary driving pressure. Meaning: patients undergoing thoracic surgery during one lung ventilation may benefit of an open lung approach strategy to avoid ventilator lung injury.
    Detailed Description
    Background: During thoracic surgery in lateral decubitus, one lung ventilation (OLV) may impair respiratory mechanics and gas exchange. The investigators tested a strategy based on an open lung approach (OLA) consisting in lung recruitment immediately followed by a decremental positive-end expiratory pressure (PEEP) titration to the best respiratory system compliance (CRS) and separately quantified the elastic properties of the lung and the chest wall. The investigators hypothesis was that this approach would improve gas exchange and increase lung compliance (CL). Methods: In thirteen patients undergoing upper left lobectomy the investigators studied lung and chest wall mechanics, transpulmonary pressure (PL), respiratory system and transpulmonary driving pressure (ΔPRS and ΔPL), gas exchange and hemodynamics at two time-points (a) during OLV at zero end-expiratory pressure (OLVpre-OLA) and (b) after the application of the open-lung strategy (OLVpost-OLA).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoxemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open lung approach
    Arm Type
    Experimental
    Arm Description
    Recruitment maneuver during OLV in thoracic surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Recruitment maneuver
    Intervention Description
    the ventilator was switched to pressure-control ventilation with a driving pressure of 20 cmH2O. After a 3 min equilibration, PEEP was applied in steps of 5,10,15 and 20 cmH2O every five respiratory breaths; subsequently, after setting a driving pressure of 15 cmH2O, PEEP was stepwise reduced, starting from 15 cmH2O, by 2 cmH2O every 2 minutes. The recruiting pressure of 20/20 was applied for six breaths. During the decremental PEEP trial, CRS was measured at every step. The PEEP level corresponding to highest CRS during the decremental trial was identified as the "best PEEP". Subsequently, the lungs were recruited again and the "best" PEEP was applied.
    Primary Outcome Measure Information:
    Title
    Change in respiratory mechanics before and after the open lung approach
    Description
    Respiratory mechanics parameters were recorded, digitized and collected on a personal computer through a 12-bit analog-to digital converter board (DAQCard 700; National Instrument, Austin, TX) at a sample rate of 200 Hz (ICU Lab, KleisTEK Engineering, Bari, Italy).
    Time Frame
    During surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age > 18 years, surgery and OLV lasting ≥ 60 min Exclusion Criteria: lung reduction surgery, pneumonectomy, patients with severe COPD with preoperative forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) ratio, expressed as a percentage (FEV1/FVC%) <60%, presence of large bullae, pleural diseases and/or acute or chronic uncompensated cardiac disease

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30382819
    Citation
    Rauseo M, Mirabella L, Grasso S, Cotoia A, Spadaro S, D'Antini D, Valentino F, Tullo L, Loizzi D, Sollitto F, Cinnella G. Peep titration based on the open lung approach during one lung ventilation in thoracic surgery: a physiological study. BMC Anesthesiol. 2018 Oct 31;18(1):156. doi: 10.1186/s12871-018-0624-3.
    Results Reference
    derived

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    The Open Lung Approach During One Lung Ventilation in Thoracic Surgery

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