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Noninvasive Ventilation After Coronary Bypass Grafting

Phase 4
Completed
Conditions
Coronary Artery Bypass
Interventions
Other: Conventional ventilator
Other: Specific ventilator
Registration Number
NCT02352376
Lead Sponsor
Federal University of Uberlandia
Brief Summary

This is a prospective, quantitative, randomized, crossover study. Were included in this study 10 people in the Intensive Care Unit at University Hospital in Uberlandia, on the first day of the postoperative coronary artery bypass graft (CABG). For data collection was performed randomization on the block (2: 4), to determine the first technique to be used and then a wash-out period of one hour was allowed for the research subject reaches the systemic arterial pressure, heart rate, respiratory rate and oxygen saturation baseline. And after, for cross-over, the second technique was performed. Non-invasive ventilation was performed for 30 minutes each ventilator. All subjects underwent noninvasive ventilation using two models of ventilators, they are conventional (designed for invasive ventilation but is also used in non-invasive ventilation mode) and specific (designed for non-invasive ventilation). Hemodynamic, autonomic and respiratory variables are monitored. We use the hypothesis that non-invasive ventilation performed with two fan models can alter autonomic function and that there is hemodynamic changes related to autonomic function in different ventilators in postoperative coronary artery bypass grafting.

Detailed Description

Background: The patients in postoperative coronary artery bypass graft (CABG) have impaired cardiac autonomic function. However, no studies have evaluated the influence of different ventilators during noninvasive ventilation (NIV) in the autonomic modulation associated with hemodynamic changes. Objective: Evaluate the autonomic behavior and hemodynamic changes during the execution of the NIV with two models of mechanical ventilators in subjects after CABG. Material and Methods: This is quantitative randomized, prospective, crossover study. The subjects were selected on first day postoperatively CABG and was performance NIV procedure using two different ventilators: conventional ventilator and specific ventilator for the use of NIV for 30 minutes, each. Block randomization was used to determine the technique that begins to approach then by crossover, perform the sequential technique. The heart rate variability (HRV), heart rate, respiratory rate, oxygen peripheral saturation and arterial pressure were evaluated before procedure, in the instants 5, 10, 15, 20, 25, 30 minutes during NIV each and 15 minutes after the end of the NIV application. HRV was evaluated using the time and frequency domain.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Specific ventilatorConventional ventilator30 minutes of non-invasive ventilation was performed with specific respirator. The order of the procedures was determined by randomization.
Conventional ventilatorConventional ventilator30 minutes of non-invasive ventilation was performed with conventional ventilator.The order of the procedures was determined by randomization.
Conventional ventilatorSpecific ventilator30 minutes of non-invasive ventilation was performed with conventional ventilator.The order of the procedures was determined by randomization.
Specific ventilatorSpecific ventilator30 minutes of non-invasive ventilation was performed with specific respirator. The order of the procedures was determined by randomization.
Primary Outcome Measures
NameTimeMethod
Variability of heart rate front the use of noninvasive ventilation in two different ventilators in patients after cardiac surgery, measured by Polar RS800 CX.3 hours

The autonomic variables evaluated are: standard deviation of all normal RR intervals recorded in a time interval (SDNN); standard deviation of the mean of normal RR intervals every 5 minutes at a time, expressed in milliseconds (SDANN); percentage of R-Ri with adjacent difference of duration greater than 50 milliseconds (pNN50) and the square root of the average squared difference between the adjacent R-Ri normal in a period of time, expressed in milliseconds (rMSSD). All variables will be assessed by Polar RS800CX

Secondary Outcome Measures
NameTimeMethod
Change in the indices of variability of heart rate, systolic blood pressure, diastolic blood pressure and heart rate during noninvasive ventilation with two models of ventilatotors in patients after cardiac surgery.3 hours
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