Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in Post-Operative Cardiac Surgery
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Surgery||Device: Non invasive ventilation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|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)|
|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|
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
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03371628
|Contact: Alita L Novaes, email@example.com|
|Contact: Wagner Leite, specialist||+5581981410170|
|Alita Paula Lopes de Novaes||Recruiting|
|Recife, Pernambuco, Brazil, 50751380|
|Contact: Alita Paula L de Novaes 81991610199 firstname.lastname@example.org|
|Study Director:||Daniella C Brandão, PhD||UFPE|