Noninvasive Ventilation After Coronary Bypass Grafting (Physiotherapy)

January 28, 2015 updated by: Célia Regina Lopes, Federal University of Uberlandia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Investigators

  • Principal Investigator: Valdeci C Dionísio, Dr., Federal University of Uberlândia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11104413.6.0000.5152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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