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Effects of PEEP on Parameters of Tissue Perfusion in Patients Post Cardiac Surgery

Primary Purpose

Coronary Artery Disease, Coronary Artery Bypass Grafting, Acute Lung Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group G5
Group G10
Group G15
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Acute Lung Injury, postoperative of cardiac surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective and isolated CABG, ejection fraction greater than 40%

Exclusion Criteria:

  • patients with a diagnosis of pulmonary disease, emergency surgery and mechanical ventilation prior to surgery.

Postoperative patients who had radiological abnormalities suggestive of pneumothorax, atrial or ventricular arrhythmias, electrical ischemic changes on ECG, pulse pressure variation of more than 13, hemodynamic instability characterized by mean arterial pressure less than 60 mmHg, nor epinephrine greater than 0.5 mcg/Kg/ min and the presence of increased bleeding through the drains (greater than 2 ml \ kg \ h) the protocol was discontinued and the patient excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Experimental

    Experimental

    Arm Label

    Group G5

    Group G10

    Group G15

    Arm Description

    Patients submitted to CABG and peep 5

    Patients submitted to CABG and peep 10

    Patients submitted to CABG and peep 15

    Outcomes

    Primary Outcome Measures

    Pulmonary events
    Pleural effusion was considered relevant when exceeding the phrenicocostal angle and fluid drainage was monitored hourly. Atelectasis was acknowledged when a clear atelectasis radiologic shadow exceeded 15 mm in width, with linear atelectasis
    Arterial oxygenation
    arterial blood gas measurements (partial pressure of arterial oxygen [PaO2]
    Tissue oxygenation
    (central venous oxygen saturation , arterial blood lactate and venoarterial CO2 difference

    Secondary Outcome Measures

    Length of intensive care unit (ICU) stay
    Days since surgery until ICU discharge
    Length of Hospital Stay
    Days since surgery until Hospital discharge
    Duration of mechanical ventilation
    Hours since surgery until extubation

    Full Information

    First Posted
    November 21, 2018
    Last Updated
    November 27, 2018
    Sponsor
    Federal University of São Paulo
    Collaborators
    Vanessa Marques Ferreira
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03753022
    Brief Title
    Effects of PEEP on Parameters of Tissue Perfusion in Patients Post Cardiac Surgery
    Official Title
    Effects of PEEP on Parameters of Tissue Perfusion and Clinical Outcomes After Coronary Artery Bypass Graft Surgery - a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2012 (Actual)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo
    Collaborators
    Vanessa Marques Ferreira

    4. Oversight

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

    5. Study Description

    Brief Summary
    Pulmonary dysfunction is a condition inherent in cardiac surgery because of various interventions, such as general anesthesia, a median sternotomy, cardiopulmonary bypass and establishment of internal thoracic artery dissection. In situations when there is a deterioration in oxygenation, increased positive pressure on the airways end pressure (PEEP) can be used as therapeutic mode by reversing severe hypoxemia resulting pulmonary shunt. But the use of PEEP has been associated to reduced cardiac output, due mainly to decrease systemic venous return consequent to increased intrathoracic pressure, and thus might reduce tissue oxygenation. Moreover, the increased transpulmonary gradient may also impair right ventricular ejection exacerbating the hemodynamic consequences in some patients, which in clinical practice this diagnosis may be difficult to perform. In hypovolemic patients or those with cardiac changes may become even more pronounced, resulting in accentuation of low flow and systemic hypotension entailing changes in markers of tissue perfusion commonly measured by venous saturation central difference venoarterial carbon dioxide and lactate. The hypothesis of the investigators is that PEEP of 10 cmH2O and 15 cmH2O can be applied to reverse lung damage in patients in the immediate postoperative myocardial revascularization without repercussion tissue importantly in markers of tissue perfusion. The objective is to evaluate the effects of different optimization levels of PEEP on gas exchange and influences the tissue perfusion after coronary artery bypass graft surgery.
    Detailed Description
    This is a prospective, randomized study and will be performed on patients who accept coronary artery bypass grafting with cardiopulmonary bypass, the conscious openness to participate in the study. Age, sex, body mass index (BMI), smoking habits, diagnosis, additional diseases, drugs used, surgery, intervention, peroperative supportive treatments, left ventricular ejection fraction, post operative blood and cardiopulmonary bypass (CPB) time (min), cross clamp time (min), duration of operation, postoperative extubation period, intensive care day of hospitalization, day of hospitalization will be recorded.The study was planned in 3 groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10 [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30 minutes and then returned to 5 cmH2O (time 2)]. Group G15 [after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)]. At each time of protocol (0, 1 and 2) will be collected: arterial blood gas measurements (partial pressure of arterial oxygen [PaO2] and partial pressure of carbon dioxide ([PaCO2]), the ratio between the partial oxygen pressure, inspired oxygen fraction (PaO2/FiO2) and pH. Also, will be performed parameters of tissue perfusion: central venous oxygen saturation ([SVO2]), arterial blood lactate, venoarterial CO2 difference ([Dif VA CO2]) and vital signs. In all other respects, treatment will follow the standard of care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Coronary Artery Bypass Grafting, Acute Lung Injury
    Keywords
    Acute Lung Injury, postoperative of cardiac surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    The study was planned in 3 groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10 [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30 minutes and then returned to 5 cm H2O (time 2)]. Group G15 [after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)].
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    125 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group G5
    Arm Type
    Sham Comparator
    Arm Description
    Patients submitted to CABG and peep 5
    Arm Title
    Group G10
    Arm Type
    Experimental
    Arm Description
    Patients submitted to CABG and peep 10
    Arm Title
    Group G15
    Arm Type
    Experimental
    Arm Description
    Patients submitted to CABG and peep 15
    Intervention Type
    Other
    Intervention Name(s)
    Group G5
    Intervention Description
    Submitted to peep 5
    Intervention Type
    Other
    Intervention Name(s)
    Group G10
    Intervention Description
    Submitted to peep 10
    Intervention Type
    Other
    Intervention Name(s)
    Group G15
    Intervention Description
    Submitted to peep 15
    Primary Outcome Measure Information:
    Title
    Pulmonary events
    Description
    Pleural effusion was considered relevant when exceeding the phrenicocostal angle and fluid drainage was monitored hourly. Atelectasis was acknowledged when a clear atelectasis radiologic shadow exceeded 15 mm in width, with linear atelectasis
    Time Frame
    Through study completion, an average of 24 hours after surgery
    Title
    Arterial oxygenation
    Description
    arterial blood gas measurements (partial pressure of arterial oxygen [PaO2]
    Time Frame
    Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
    Title
    Tissue oxygenation
    Description
    (central venous oxygen saturation , arterial blood lactate and venoarterial CO2 difference
    Time Frame
    Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
    Secondary Outcome Measure Information:
    Title
    Length of intensive care unit (ICU) stay
    Description
    Days since surgery until ICU discharge
    Time Frame
    From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery ]
    Title
    Length of Hospital Stay
    Description
    Days since surgery until Hospital discharge
    Time Frame
    From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery ]
    Title
    Duration of mechanical ventilation
    Description
    Hours since surgery until extubation
    Time Frame
    Through study completion, an average of 24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: elective and isolated CABG, ejection fraction greater than 40% Exclusion Criteria: patients with a diagnosis of pulmonary disease, emergency surgery and mechanical ventilation prior to surgery. Postoperative patients who had radiological abnormalities suggestive of pneumothorax, atrial or ventricular arrhythmias, electrical ischemic changes on ECG, pulse pressure variation of more than 13, hemodynamic instability characterized by mean arterial pressure less than 60 mmHg, nor epinephrine greater than 0.5 mcg/Kg/ min and the presence of increased bleeding through the drains (greater than 2 ml \ kg \ h) the protocol was discontinued and the patient excluded from the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of PEEP on Parameters of Tissue Perfusion in Patients Post Cardiac Surgery

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