Noninvasive Ventilation After Coronary Bypass Grafting

NCT02352376 | Completed Phase 4 DMC

• 1 other identifier: 11104413.6.0000.5152
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Bypass

Keywords

Noninvasive ventilation; Heart rate variability; Thoracic surgery

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (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.

  3 hours

Study Arms (2)

Conventional ventilator

OTHER

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

Other: Conventional ventilator; Other: Specific ventilator

Specific ventilator

OTHER

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

Other: Conventional ventilator; Other: Specific ventilator

Interventions

Conventional ventilator OTHER

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

Conventional ventilator; Specific ventilator

Specific ventilator OTHER

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

Conventional ventilator; Specific ventilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Related Publications (11)

• 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.

  PMID: 8737210 RESULT

• 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.

  PMID: 24715877 RESULT

• 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.

  PMID: 21085891 RESULT

• 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.

  PMID: 24520952 RESULT

• 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.

  PMID: 24965685 RESULT

• 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.

  PMID: 15201553 RESULT

• 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.

  PMID: 16306058 RESULT

• 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.

  PMID: 24286408 RESULT

• 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.

  PMID: 19017864 RESULT

• 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.

  PMID: 25278968 RESULT

• 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.

  PMID: 21167508 RESULT

Study Officials

• Valdeci C Dionísio, Dr.

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EFFECTS OF NON INVASIVE VENTILATION ON HEART RATE VARIABILITY AFTER CORONARY BYPASS GRAFTING: COMPARISON BETWEEN DIFFERENT VENTILATORS

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: February 2, 2015
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 2, 2015

Record last verified: 2015-01