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
About this trial
This is an interventional supportive care trial for Heart Diseases focused on measuring Postoperative Care, Postoperative Period, Heart Surgery
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
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
NCT ID
NCT02767687
First Posted
March 28, 2016
Last Updated
May 7, 2016
Sponsor
Federal University of São Paulo
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
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