Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in Post-Operative Cardiac Surgery
NCT ID: NCT03371628
Last Updated: 2017-12-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
26 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-12-06
Study Completion Date
2018-02-28
Brief Summary
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NTRODUCTION: cardiac surgery can lead to pulmonary complications such as hypoxemia and atelectasis. Noninvasive ventilation has been used to prevent and treat such complications. Electrical impedance tomography has been a useful tool in bedside evaluation of ventilation and pulmonary ventilation. OBJECTIVE: To compare the effects of non-invasive ventilation with oxygen therapy in cardiac post-operative patients. MATERIALS AND METHODS: It will be a randomized controlled clinical trial where patients will be divided into two groups: a group that will perform NIV for 1 hour and the group that will only use oxygen therapy. They will be evaluated through Electrical Impedance Tomography and arterial gasometry analysis just before extubation, soon after extubation, during the intervention and after the intervention for a period of 2 hours after extubation. EXPECTED RESULTS: It is expected that the NIV group will present higher pulmonary ventilation and aeration and better gas exchange than the oxygen therapy group, and that the time of therapeutic effect will be higher in the NIV group.
Detailed Description
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The proposal basically consists of Validation of the hypothesis: The use of Non-invasive Ventilation in patients in the postoperative cardiac surgery results in greater ventilation, greater aeration, and improved gas exchange when compared to the oxygen therapy group.
The use of noninvasive ventilation in the postoperative cardiac surgery has been widely used in clinical practice, but the evidence of the benefits of this technique in this population in relation to some criteria have not yet been elucidated in the scientific literature, such as the effect of NIV in ventilation and pulmonary ventilation, and how long does this effect last.
The use of noninvasive ventilation in the postoperative cardiac surgery has been widely used in clinical practice, but the evidence of the benefits of this technique in this population in relation to some criteria have not yet been elucidated in the scientific literature, such as the effect of NIV in ventilation and pulmonary ventilation, and how long does this effect last.
Conditions
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Thoracic Surgery
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A parallel group study is a simple and commonly used clinical design which compares two treatments. Usually a test therapy is compared with a standard therapy. The allocation of subjects to groups is usually achieved by randomisation. The groups are typically named the treatment group and the control group. Parallel group designs do not require the same number of subjects in each group, although often similar numbers are observed. The design is commonly used in randomised controlled trials. Statistical analysis often boils down to a simple t-test of the between group difference in the outcome, which is usually a mean or a proportion.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Group VNI 1h
Intervention: Non invasive ventilation, applied for 1 hour
Group Type
EXPERIMENTAL
Non invasive ventilation
Intervention Type
DEVICE
Non invasive ventilation is a mode of mechanical ventilation that does not require the use of artificial airway.
Group O2
Oxygen therapy
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Non invasive ventilation
Non invasive ventilation is a mode of mechanical ventilation that does not require the use of artificial airway.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Immediate postoperative period of cardiac surgery
* age between 18 and 65 years
* BMI between 18.5 and 30 kg / m2
* Patients still intubated when admitted to the ICU
* without previous history of severe pulmonary diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, or chronic renal failure, or associated neuromuscular diseases
* age between 18 and 65 years
* BMI between 18.5 and 30 kg / m2
* Patients still intubated when admitted to the ICU
* without previous history of severe pulmonary diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, or chronic renal failure, or associated neuromuscular diseases
Exclusion Criteria
* Patients considered to be at risk for extubation failure (hypercapnia, more than failure in the autonomic test, AVM time greater than 72 hours, ineffective cough)
* Cardiopulmonary bypass time more than 150 minutes
* Hemodynamic instability (arrhythmias, cardiogenic shock, severe hypotension with SBP \<90mmHg)
* Episodes of abdominal distension, nausea and vomiting
* Hypoxemia (PO2 \<50mmHg with FiO2 50%) or hypercapnia (PaCO2\> 55mmHg with pH \<7.30)
* Patients who are at high surgical risk according to Euroscore II
* Cardiopulmonary bypass time more than 150 minutes
* Hemodynamic instability (arrhythmias, cardiogenic shock, severe hypotension with SBP \<90mmHg)
* Episodes of abdominal distension, nausea and vomiting
* Hypoxemia (PO2 \<50mmHg with FiO2 50%) or hypercapnia (PaCO2\> 55mmHg with pH \<7.30)
* Patients who are at high surgical risk according to Euroscore II
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Universidade Federal de Pernambuco
OTHER
Sponsor Role
lead
Responsible Party
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Alita Paula Lopes de Novaes
Master´s program studant
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Daniella C Brandão, PhD
Role: STUDY_DIRECTOR
UFPE
Locations
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Alita Paula Lopes de Novaes
Recife, Pernambuco, Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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Wagner Leite, specialist
Role: CONTACT
Phone: +5581981410170
Facility Contacts
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Alita Paula L de Novaes
Role: primary
References
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BACKGROUND
Other Identifiers
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Tomografia de Impedância
Identifier Type: -
Identifier Source: org_study_id