search
Back to results

Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery

Primary Purpose

Heart Diseases, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Noninvasive ventilation
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Diseases focused on measuring Postoperative Care, Postoperative Period, Heart Surgery

Eligibility Criteria

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

Inclusion Criteria:

  • Presence of central venous catheter
  • Invasive arterial pressure catheter
  • Invasive mechanical ventilation

Exclusion Criteria:

  • Chronic obstructive pulmonary disease
  • Morbid obesity
  • Hemodynamic instability
  • Spontaneous breathing
  • Need of invasive mechanical ventilation for more than 24 hours
  • Intolerance to noninvasive mechanical ventilation
  • Extubation failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Noninvasive ventilation (NIV)

    Arm Description

    Noninvasive mechanical ventilation is a resource used to treat respiratory failure or to reestablish respiratory comfort and function. It is commonly used in the ICU with a regular mechanical ventilator and is offered using an interface that connects the machine to the patient. The interface used for adults and in this study, was a silicon facial mask that covers the nose and mouth of the patient, allowing him or her to open the eyes.

    Outcomes

    Primary Outcome Measures

    Evaluation of central venous oxygen saturation to determine tissue perfusion
    All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the central venous catheter at different times to evaluate central venous oxygen saturation. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
    Evaluation of arterial lactate to determine tissue perfusion
    All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the arterial invasive catheter at different times to evaluate arterial lactate. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.

    Secondary Outcome Measures

    Respiratory complications during hospitalization
    Respiratory events as pleural effusion and atelectasis will be evaluated by a professional blind to the protocol of study and will be recorded.
    Hemodinamycs complications during hospitalization
    Hemodinamycs events as arrhythmia, hypotension and cardiac arrest will be evaluated by a professional blind to the protocol of study and will be recorded.

    Full Information

    First Posted
    March 28, 2016
    Last Updated
    May 7, 2016
    Sponsor
    Federal University of São Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02767687
    Brief Title
    Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery
    Official Title
    Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery.
    Detailed Description
    Patients submitted to open chest cardiac surgery will be enrolled after ICU admission. These patients will be submitted to noninvasive mechanical ventilation with continuous positive airway pressure right after extubation and tissue perfusion markers (central venous oxygen saturation (SVcO2) and lactate) will be obtained via central venous catheter. Noninvasive mechanical ventilation is a common resource in the ICU to reduce extubation failures and to improve clinical outcomes, whether it can influence tissue perfusion remains unclear. This study evaluates whether noninvasive ventilation affects tissue perfusion and whether tissue perfusion markers in the ICU are correlated with better clinical results for patients after heart surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Diseases, Coronary Artery Disease
    Keywords
    Postoperative Care, Postoperative Period, Heart Surgery

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Noninvasive ventilation (NIV)
    Arm Type
    Experimental
    Arm Description
    Noninvasive mechanical ventilation is a resource used to treat respiratory failure or to reestablish respiratory comfort and function. It is commonly used in the ICU with a regular mechanical ventilator and is offered using an interface that connects the machine to the patient. The interface used for adults and in this study, was a silicon facial mask that covers the nose and mouth of the patient, allowing him or her to open the eyes.
    Intervention Type
    Other
    Intervention Name(s)
    Noninvasive ventilation
    Other Intervention Name(s)
    NIV
    Intervention Description
    Twenty minutes after extubation all subjects will receive noninvasive ventilation delivered through a facial mask with an ICU ventilator with NIV option for 60 minutes. NIV associates pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O).
    Primary Outcome Measure Information:
    Title
    Evaluation of central venous oxygen saturation to determine tissue perfusion
    Description
    All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the central venous catheter at different times to evaluate central venous oxygen saturation. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
    Time Frame
    Through study completion, an average of 1 year
    Title
    Evaluation of arterial lactate to determine tissue perfusion
    Description
    All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the arterial invasive catheter at different times to evaluate arterial lactate. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
    Time Frame
    Through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Respiratory complications during hospitalization
    Description
    Respiratory events as pleural effusion and atelectasis will be evaluated by a professional blind to the protocol of study and will be recorded.
    Time Frame
    Through study completion, an average of 1 year
    Title
    Hemodinamycs complications during hospitalization
    Description
    Hemodinamycs events as arrhythmia, hypotension and cardiac arrest will be evaluated by a professional blind to the protocol of study and will be recorded.
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Presence of central venous catheter Invasive arterial pressure catheter Invasive mechanical ventilation Exclusion Criteria: Chronic obstructive pulmonary disease Morbid obesity Hemodynamic instability Spontaneous breathing Need of invasive mechanical ventilation for more than 24 hours Intolerance to noninvasive mechanical ventilation Extubation failure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Solange Guizilini, PhD
    Organizational Affiliation
    Federal University of Sao Paulo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No participant data will be made available, however every subject was provided the investigator's e-mail address as well a phone number and was encouraged to call or send an e-mail in case of doubt or to receive information regarding the research.
    Citations:
    PubMed Identifier
    29895702
    Citation
    Marcondi NO, Rocco IS, Bolzan DW, Pauletti HO, Begot I, Anjos NR, Moreira RSL, Nasrala ML, Arena R, Gomes WJ, Guizilini S. Noninvasive Ventilation After Coronary Artery Bypass Grafting in Subjects With Left-Ventricular Dysfunction. Respir Care. 2018 Jul;63(7):879-885. doi: 10.4187/respcare.05851. Epub 2018 Jun 12.
    Results Reference
    derived

    Learn more about this trial

    Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery

    We'll reach out to this number within 24 hrs