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Open Lung Approach Versus Standard Protective Strategies

Primary Purpose

Lung Collapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OLA
RM-5
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Collapse

Eligibility Criteria

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

Inclusion Criteria:

  • ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection

Exclusion Criteria:

  • i) laparoscopic surgery, ii) patients with previous respiratory disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    OLA

    RM-5

    Arm Description

    recruitment maneuver + individualized PEEP

    recruitment maneuver + fixed standard PEEP

    Outcomes

    Primary Outcome Measures

    driving pressure
    The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications

    Secondary Outcome Measures

    ventilatory efficiency
    Ventilatory efficiency measured with volumetric capnography which includes dead space and tidal elimination of carbon dioxide.

    Full Information

    First Posted
    June 5, 2016
    Last Updated
    April 25, 2017
    Sponsor
    Fundación para la Investigación del Hospital Clínico de Valencia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02798133
    Brief Title
    Open Lung Approach Versus Standard Protective Strategies
    Official Title
    Open Lung Approach Versus Standard Protective Strategies: Effects on Driving Pressure and Ventilatory Efficiency During Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundación para la Investigación del Hospital Clínico de Valencia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OLA
    Arm Type
    Experimental
    Arm Description
    recruitment maneuver + individualized PEEP
    Arm Title
    RM-5
    Arm Type
    Active Comparator
    Arm Description
    recruitment maneuver + fixed standard PEEP
    Intervention Type
    Procedure
    Intervention Name(s)
    OLA
    Intervention Description
    PEEP titration trial for best Cdyn after the alveolar recruitment maneuver
    Intervention Type
    Procedure
    Intervention Name(s)
    RM-5
    Intervention Description
    Fixed standard PEEP after the alveolar recruitment maneuver
    Primary Outcome Measure Information:
    Title
    driving pressure
    Description
    The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications
    Time Frame
    intraoperative
    Secondary Outcome Measure Information:
    Title
    ventilatory efficiency
    Description
    Ventilatory efficiency measured with volumetric capnography which includes dead space and tidal elimination of carbon dioxide.
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection Exclusion Criteria: i) laparoscopic surgery, ii) patients with previous respiratory disease.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    26947624
    Citation
    Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4. Erratum In: Lancet Respir Med. 2016 Jun;4(6):e34.
    Results Reference
    background
    PubMed Identifier
    26672923
    Citation
    Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.
    Results Reference
    background
    PubMed Identifier
    24557111
    Citation
    Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
    Results Reference
    background
    PubMed Identifier
    28493943
    Citation
    Ferrando C, Suarez-Sipmann F, Tusman G, Leon I, Romero E, Gracia E, Mugarra A, Arocas B, Pozo N, Soro M, Belda FJ. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177399. doi: 10.1371/journal.pone.0177399. eCollection 2017.
    Results Reference
    derived

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    Open Lung Approach Versus Standard Protective Strategies

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