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Lung Recruitment Improves Right Ventricle Performance

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lung recruitment maneuver
Sponsored by
Hospital Privado de Cordoba, Argentina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atelectasis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cardiovascular surgery with cardiopulmonary bypass.
  • Patients with a New York Heart Association (NYHA) class I-II,
  • Pre-operative left ventricular ejection fraction ≥ 50 %.
  • Euroscore ≤ 6.

Exclusion Criteria:

  • TEE contraindications.
  • Hemodynamically unstable
  • Needi for inotropic support

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Recruitment maneuver group

    Arm Description

    Patients received standard protective ventilation along the protocol.

    Patient received a lung recruitment maneuver after cardiopulmonary bypass. The recruitment maneuver consists in 10 breaths at 40/20 cmH2O of plateau pressure and PEEP, respectively. Then, the .ventilatory settings back to protective ventilation but adding 10 cmH2O of PEEP to keep the lungs open.

    Outcomes

    Primary Outcome Measures

    Right ventricle assessment by transesophageal echocardiography

    Secondary Outcome Measures

    Atelectasis assessment by transesophageal echocardiography
    PaO2 and respiratory compliance

    Full Information

    First Posted
    June 5, 2016
    Last Updated
    June 12, 2016
    Sponsor
    Hospital Privado de Cordoba, Argentina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02795208
    Brief Title
    Lung Recruitment Improves Right Ventricle Performance
    Official Title
    Lung Recruitment Improves Right Ventricle Performance After Cardio-Pulmonary Bypass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Privado de Cordoba, Argentina

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study test whether a lung recruitment maneuver improves the right ventricle performance after cardiopulmonary bypass. Half of the patients received an standard protective ventilation and the other half the same ventilatory pattern after a lung recruitment maneuver.
    Detailed Description
    Atelectasis is developed in 90% of anesthetized patients after surgery. Protective ventilation with low tidal volumes and positive-end expiratory pressure (PEEP) promotes atelectasis with the potential right ventricle dysfunction induced by the increment in afterload (activation of the pulmonary hypoxic vasocontriction reflex). Lung recruitment can improve the right ventricle performance caused by atelectasis because the pulmonary hypoxic vasocontriction reflex desapear in a normal aerated lungs.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients received standard protective ventilation along the protocol.
    Arm Title
    Recruitment maneuver group
    Arm Type
    Experimental
    Arm Description
    Patient received a lung recruitment maneuver after cardiopulmonary bypass. The recruitment maneuver consists in 10 breaths at 40/20 cmH2O of plateau pressure and PEEP, respectively. Then, the .ventilatory settings back to protective ventilation but adding 10 cmH2O of PEEP to keep the lungs open.
    Intervention Type
    Procedure
    Intervention Name(s)
    Lung recruitment maneuver
    Intervention Description
    The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (20 cmH2O of PEEP + 20 cmH2O of driving pressure) for 10 breaths.
    Primary Outcome Measure Information:
    Title
    Right ventricle assessment by transesophageal echocardiography
    Time Frame
    intraoperative
    Secondary Outcome Measure Information:
    Title
    Atelectasis assessment by transesophageal echocardiography
    Time Frame
    intraoperative
    Title
    PaO2 and respiratory compliance
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: cardiovascular surgery with cardiopulmonary bypass. Patients with a New York Heart Association (NYHA) class I-II, Pre-operative left ventricular ejection fraction ≥ 50 %. Euroscore ≤ 6. Exclusion Criteria: TEE contraindications. Hemodynamically unstable Needi for inotropic support
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Silvina Longo, MD
    Organizational Affiliation
    Hospital Privado de Córdoba
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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