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Noninvasive Ventilation After Coronary Bypass Grafting (Physiotherapy)

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ClinicalTrials.gov Identifier: NCT02352376
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Célia Regina Lopes, 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Other: Conventional ventilator Other: Specific ventilator Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Non Invasive Ventilation on Heart Rate Variability After Coronary Bypass Grafting: Comparison Between Different Ventilator
Study Start Date : March 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Conventional ventilator
30 minutes of non-invasive ventilation was performed with conventional ventilator.The order of the procedures was determined by randomization.
Other: Conventional ventilator
A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).

Other: Specific ventilator
A ventilator was used designed for non-invasive ventilation has an algorithm that calculates the loss of pressure and automatically compensates for leak

Specific ventilator
30 minutes of non-invasive ventilation was performed with specific respirator. The order of the procedures was determined by randomization.
Other: Conventional ventilator
A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).

Other: Specific ventilator
A ventilator was used designed for non-invasive ventilation has an algorithm that calculates the loss of pressure and automatically compensates for leak




Primary Outcome Measures :
  1. Variability of heart rate front the use of noninvasive ventilation in two different ventilators in patients after cardiac surgery, measured by Polar RS800 CX. [ Time Frame: 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 :
  1. 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. [ Time Frame: 3 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Age over 18 years .Who were breathing spontaneously with peripheral oxygen saturation (SpO2) ≥ 90% and supplemental oxygen ≤ 3 l / min.
  • Indication for use of NIV

Exclusion criteria

  • Hemodynamic instability with hypertensive response being considered systolic blood pressure (SBP) greater than 180 mmHg and diastolic blood pressure (DBP) greater than 110 mmHg, or difference in SBP and DBP less than 20 mmHg or framework shock considering SBP <90 mmHg and / or DBP <50 mmHg, since the normal SBP were between 90-130 mmHg and DBP 60-90 mmHg
  • Presence of active cardiac pacemaker
  • Invasive mechanical ventilation more than 24 hours
  • Use of intra aortic balloon
  • Postoperatively Myocardial infarction after surgery
  • Ineffective cough with bronchial hypersecretion
  • Inability to adequately swallowing and/or protect the airway
  • Abdominal distension
  • Nausea
  • Vomiting

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 ClinicalTrials.gov identifier (NCT number): NCT02352376


Sponsors and Collaborators
Federal University of Uberlandia
Investigators
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Principal Investigator: Valdeci C Dionísio, Dr. Federal University of Uberlandia
Publications of Results:

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Responsible Party: Célia Regina Lopes, EFFECTS OF NON INVASIVE VENTILATION ON HEART RATE VARIABILITY AFTER CORONARY BYPASS GRAFTING: COMPARISON BETWEEN DIFFERENT VENTILATORS, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT02352376    
Other Study ID Numbers: 11104413.6.0000.5152
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Keywords provided by Célia Regina Lopes, Federal University of Uberlandia:
Noninvasive ventilation
Heart rate variability
Thoracic surgery