Clinical Trials Directory

Trials / Completed

CompletedNCT02352376

Noninvasive Ventilation After Coronary Bypass Grafting

Effects of Non Invasive Ventilation on Heart Rate Variability After Coronary Bypass Grafting: Comparison Between Different Ventilator

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Federal University of Uberlandia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERConventional ventilatorA ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).
OTHERSpecific ventilatorA ventilator was used designed for non-invasive ventilation has an algorithm that calculates the loss of pressure and automatically compensates for leak

Timeline

Start date
2013-03-01
Primary completion
2014-07-01
Completion
2014-11-01
First posted
2015-02-02
Last updated
2015-02-02

Source: ClinicalTrials.gov record NCT02352376. Inclusion in this directory is not an endorsement.