Noninvasive Ventilation After Coronary Bypass Grafting

NCT ID: NCT02352376

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-11-30

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.

Conditions

Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional ventilator

30 minutes of non-invasive ventilation was performed with conventional ventilator.The order of the procedures was determined by randomization.

Group Type: OTHER

Conventional ventilator

Intervention Type: OTHER

A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).

Specific ventilator

Intervention Type: OTHER

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.

Group Type: OTHER

Conventional ventilator

Intervention Type: OTHER

A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).

Specific ventilator

Intervention Type: OTHER

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

Interventions

Conventional ventilator

A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Célia Regina Lopes

EFFECTS OF NON INVASIVE VENTILATION ON HEART RATE VARIABILITY AFTER CORONARY BYPASS GRAFTING: COMPARISON BETWEEN DIFFERENT VENTILATORS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valdeci C Dionísio, Dr.

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

References

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

Reference Type: RESULT

PMID: 8737210 (View on PubMed)

Carnevali L, Sgoifo A. Vagal modulation of resting heart rate in rats: the role of stress, psychosocial factors, and physical exercise. Front Physiol. 2014 Mar 24;5:118. doi: 10.3389/fphys.2014.00118. eCollection 2014.

Reference Type: RESULT

PMID: 24715877 (View on PubMed)

Pantoni CB, Di Thommazo L, Mendes RG, Catai AM, Luzzi S, Amaral Neto O, Borghi-Silva A. Effects of different levels of positive airway pressure on breathing pattern and heart rate variability after coronary artery bypass grafting surgery. Braz J Med Biol Res. 2011 Jan;44(1):38-45. doi: 10.1590/s0100-879x2010007500129. Epub 2010 Nov 19.

Reference Type: RESULT

PMID: 21085891 (View on PubMed)

Ozyilmaz E, Ugurlu AO, Nava S. Timing of noninvasive ventilation failure: causes, risk factors, and potential remedies. BMC Pulm Med. 2014 Feb 13;14:19. doi: 10.1186/1471-2466-14-19.

Reference Type: RESULT

PMID: 24520952 (View on PubMed)

Sasaki K, Maruyama R. Consciously controlled breathing decreases the high-frequency component of heart rate variability by inhibiting cardiac parasympathetic nerve activity. Tohoku J Exp Med. 2014 Jul;233(3):155-63. doi: 10.1620/tjem.233.155.

Reference Type: RESULT

PMID: 24965685 (View on PubMed)

Radaelli A, Raco R, Perfetti P, Viola A, Azzellino A, Signorini MG, Ferrari AU. Effects of slow, controlled breathing on baroreceptor control of heart rate and blood pressure in healthy men. J Hypertens. 2004 Jul;22(7):1361-70. doi: 10.1097/01.hjh.0000125446.28861.51.

Reference Type: RESULT

PMID: 15201553 (View on PubMed)

Pinsky MR. Cardiovascular issues in respiratory care. Chest. 2005 Nov;128(5 Suppl 2):592S-597S. doi: 10.1378/chest.128.5_suppl_2.592S.

Reference Type: RESULT

PMID: 16306058 (View on PubMed)

Zhu GF, Wang DJ, Liu S, Jia M, Jia SJ. Efficacy and safety of noninvasive positive pressure ventilation in the treatment of acute respiratory failure after cardiac surgery. Chin Med J (Engl). 2013 Dec;126(23):4463-9.

Reference Type: RESULT

PMID: 24286408 (View on PubMed)

Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18.

Reference Type: RESULT

PMID: 19017864 (View on PubMed)

Yang LX, Zhou YJ, Wang ZJ, Li YP, Chai M. Impact of invasive treatment strategy on health-related quality of life six months after non-ST-elevation acute coronary syndrome. J Geriatr Cardiol. 2014 Sep;11(3):206-11. doi: 10.11909/j.issn.1671-5411.2014.03.003.

Reference Type: RESULT

PMID: 25278968 (View on PubMed)

Yan TD, Padang R, Poh C, Cao C, Wilson MK, Bannon PG, Vallely MP. Drug-eluting stents versus coronary artery bypass grafting for the treatment of coronary artery disease: a meta-analysis of randomized and nonrandomized studies. J Thorac Cardiovasc Surg. 2011 May;141(5):1134-44. doi: 10.1016/j.jtcvs.2010.07.001. Epub 2010 Dec 17.

Reference Type: RESULT

PMID: 21167508 (View on PubMed)

Other Identifiers

11104413.6.0000.5152

Identifier Type: -

Identifier Source: org_study_id