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Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in Post-Operative Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03371628
Recruitment Status : Unknown
Verified December 2017 by Alita Paula Lopes de Novaes, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
Alita Paula Lopes de Novaes, Universidade Federal de Pernambuco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thoracic Surgery Device: Non invasive ventilation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in the Post-Operative Cardiac Surgery: Controlled and Randomized Clinical Trial
Actual Study Start Date : December 6, 2017
Actual Primary Completion Date : December 12, 2017
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Group VNI 1h
Intervention: Non invasive ventilation, applied for 1 hour
Device: Non invasive ventilation
Non invasive ventilation is a mode of mechanical ventilation that does not require the use of artificial airway.

No Intervention: Group O2
Oxygen therapy

Primary Outcome Measures :
  1. change in electrical impedance measures [ Time Frame: data recorded 5 minutes before extubation, 5 minutes after extubation, at the first 5 minutes of therapy, 25 to 30 minutes after beginning of therapy, 55 to 60 minutes after beginning of therapy, and 1,5 hour and 2 hours after beginning of therapy ]
    impedance variation data recorded by impedance electrical tomography

Secondary Outcome Measures :
  1. change in Blood gases analysis - PaO2 (mmHg), PaCO2 (mmHg), PaO2/FiO2 [ Time Frame: recorded 5 minutes before extubation and 1 hour after extubation ]
    Collected by a Laboratory professional

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03371628

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Contact: Alita L Novaes, specialist +5581991610199
Contact: Wagner Leite, specialist +5581981410170

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Alita Paula Lopes de Novaes Recruiting
Recife, Pernambuco, Brazil, 50751380
Contact: Alita Paula L de Novaes    81991610199   
Sponsors and Collaborators
Universidade Federal de Pernambuco
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Study Director: Daniella C Brandão, PhD UFPE

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Responsible Party: Alita Paula Lopes de Novaes, Master´s program studant, Universidade Federal de Pernambuco Identifier: NCT03371628    
Other Study ID Numbers: Tomografia de Impedância
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Datas relative to the results of the use of electrical impedance tomography, besides blood gases and vital signs.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: march 2018
Access Criteria: Date will be available by a USB pen drive copy by the researchers, including date relative to electrical impedance tomography and to bloog gases

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No