Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in Post-Operative Cardiac Surgery

NCT03371628 | Unknown DMC

• 1 other identifier: Tomografia de Impedância
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

NTRODUCTION: cardiac surgery can lead to pulmonary complications such as hypoxemia and atelectasis. Noninvasive ventilation has been used to prevent and treat such complications. Electrical impedance tomography has been a useful tool in bedside evaluation of ventilation and pulmonary ventilation. OBJECTIVE: To compare the effects of non-invasive ventilation with oxygen therapy in cardiac post-operative patients. MATERIALS AND METHODS: It will be a randomized controlled clinical trial where patients will be divided into two groups: a group that will perform NIV for 1 hour and the group that will only use oxygen therapy. They will be evaluated through Electrical Impedance Tomography and arterial gasometry analysis just before extubation, soon after extubation, during the intervention and after the intervention for a period of 2 hours after extubation. EXPECTED RESULTS: It is expected that the NIV group will present higher pulmonary ventilation and aeration and better gas exchange than the oxygen therapy group, and that the time of therapeutic effect will be higher in the NIV group.

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• change in electrical impedance measures

  impedance variation data recorded by impedance electrical tomography

  data recorded 5 minutes before extubation, 5 minutes after extubation, at the first 5 minutes of therapy, 25 to 30 minutes after beginning of therapy, 55 to 60 minutes after beginning of therapy, and 1,5 hour and 2 hours after beginning of therapy

Secondary Outcomes (1)

• change in Blood gases analysis - PaO2 (mmHg), PaCO2 (mmHg), PaO2/FiO2

  recorded 5 minutes before extubation and 1 hour after extubation

Study Arms (2)

Group VNI 1h

EXPERIMENTAL

Intervention: Non invasive ventilation, applied for 1 hour

Device: Non invasive ventilation

Group O2

NO INTERVENTION

Oxygen therapy

Interventions

Non invasive ventilation DEVICE

Non invasive ventilation is a mode of mechanical ventilation that does not require the use of artificial airway.

Group VNI 1h

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Immediate postoperative period of cardiac surgery
• age between 18 and 65 years
• BMI between 18.5 and 30 kg / m2
• Patients still intubated when admitted to the ICU
• without previous history of severe pulmonary diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, or chronic renal failure, or associated neuromuscular diseases

You may not qualify if:

• Patients considered to be at risk for extubation failure (hypercapnia, more than failure in the autonomic test, AVM time greater than 72 hours, ineffective cough)
• Cardiopulmonary bypass time more than 150 minutes
• Hemodynamic instability (arrhythmias, cardiogenic shock, severe hypotension with SBP \<90mmHg)
• Episodes of abdominal distension, nausea and vomiting
• Hypoxemia (PO2 \<50mmHg with FiO2 50%) or hypercapnia (PaCO2\> 55mmHg with pH \<7.30)
• Patients who are at high surgical risk according to Euroscore II

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Alita Paula Lopes de Novaes

Recife, Pernambuco, 50751380, Brazil

RECRUITING

Related Publications (32)

• Jaber S, Chanques G, Jung B. Postoperative noninvasive ventilation. Anesthesiology. 2010 Feb;112(2):453-61. doi: 10.1097/ALN.0b013e3181c5e5f2. No abstract available.

  PMID: 20068454 BACKGROUND

• Rahmanian PB, Kroner A, Langebartels G, Ozel O, Wippermann J, Wahlers T. Impact of major non-cardiac complications on outcome following cardiac surgery procedures: logistic regression analysis in a very recent patient cohort. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):319-26; discussion 326-7. doi: 10.1093/icvts/ivt149. Epub 2013 May 10.

  PMID: 23667066 BACKGROUND

• 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 BACKGROUND

• Diodato M, Chedrawy EG. Coronary artery bypass graft surgery: the past, present, and future of myocardial revascularisation. Surg Res Pract. 2014;2014:726158. doi: 10.1155/2014/726158. Epub 2014 Jan 2.

  PMID: 25374960 BACKGROUND

• Niclauss L. Techniques and standards in intraoperative graft verification by transit time flow measurement after coronary artery bypass graft surgery: a critical review. Eur J Cardiothorac Surg. 2017 Jan;51(1):26-33. doi: 10.1093/ejcts/ezw203. Epub 2016 Jun 13.

  PMID: 27298393 BACKGROUND

• Yazdannik A, Bollbanabad HM, Mirmohammadsadeghi M, Khalifezade A. The effect of incentive spirometry on arterial blood gases after coronary artery bypass surgery (CABG). Iran J Nurs Midwifery Res. 2016 Jan-Feb;21(1):89-92. doi: 10.4103/1735-9066.174761.

  PMID: 26985228 BACKGROUND

• Al Jaaly E, Fiorentino F, Reeves BC, Ind PW, Angelini GD, Kemp S, Shiner RJ. Effect of adding postoperative noninvasive ventilation to usual care to prevent pulmonary complications in patients undergoing coronary artery bypass grafting: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 Oct;146(4):912-8. doi: 10.1016/j.jtcvs.2013.03.014. Epub 2013 Apr 11.

  PMID: 23582830 BACKGROUND

• Kotani T, Tanabe H, Yusa H, Saito S, Yamazaki K, Ozaki M. Electrical impedance tomography-guided prone positioning in a patient with acute cor pulmonale associated with severe acute respiratory distress syndrome. J Anesth. 2016 Feb;30(1):161-5. doi: 10.1007/s00540-015-2084-y. Epub 2015 Oct 7.

  PMID: 26446805 BACKGROUND

• Vogt B, Pulletz S, Elke G, Zhao Z, Zabel P, Weiler N, Frerichs I. Spatial and temporal heterogeneity of regional lung ventilation determined by electrical impedance tomography during pulmonary function testing. J Appl Physiol (1985). 2012 Oct;113(7):1154-61. doi: 10.1152/japplphysiol.01630.2011. Epub 2012 Aug 16.

  PMID: 22898553 BACKGROUND

• Parolari A, Poggio P, Myasoedova V, Songia P, Bonalumi G, Pilozzi A, Pacini D, Alamanni F, Tremoli E. Biomarkers in Coronary Artery Bypass Surgery: Ready for Prime Time and Outcome Prediction? Front Cardiovasc Med. 2016 Jan 5;2:39. doi: 10.3389/fcvm.2015.00039. eCollection 2015.

  PMID: 26779491 BACKGROUND

• Mendes RG, de Souza CR, Machado MN, Correa PR, Di Thommazo-Luporini L, Arena R, Myers J, Pizzolato EB, Borghi-Silva A. Predicting reintubation, prolonged mechanical ventilation and death in post-coronary artery bypass graft surgery: a comparison between artificial neural networks and logistic regression models. Arch Med Sci. 2015 Aug 12;11(4):756-63. doi: 10.5114/aoms.2015.48145. Epub 2015 Aug 11.

  PMID: 26322087 BACKGROUND

• Kochamba GS, Yun KL, Pfeffer TA, Sintek CF, Khonsari S. Pulmonary abnormalities after coronary arterial bypass grafting operation: cardiopulmonary bypass versus mechanical stabilization. Ann Thorac Surg. 2000 May;69(5):1466-70. doi: 10.1016/s0003-4975(00)01142-5.

  PMID: 10881824 BACKGROUND

• Chiumello D, Chevallard G, Gregoretti C. Non-invasive ventilation in postoperative patients: a systematic review. Intensive Care Med. 2011 Jun;37(6):918-29. doi: 10.1007/s00134-011-2210-8. Epub 2011 Mar 18.

  PMID: 21424246 BACKGROUND

• Glossop AJ, Shephard N, Bryden DC, Mills GH. Non-invasive ventilation for weaning, avoiding reintubation after extubation and in the postoperative period: a meta-analysis. Br J Anaesth. 2012 Sep;109(3):305-14. doi: 10.1093/bja/aes270.

  PMID: 22879654 BACKGROUND

• Perrin C, Jullien V, Venissac N, Berthier F, Padovani B, Guillot F, Coussement A, Mouroux J. Prophylactic use of noninvasive ventilation in patients undergoing lung resectional surgery. Respir Med. 2007 Jul;101(7):1572-8. doi: 10.1016/j.rmed.2006.12.002. Epub 2007 Jan 25.

  PMID: 17257820 BACKGROUND

• Olper L, Corbetta D, Cabrini L, Landoni G, Zangrillo A. Effects of non-invasive ventilation on reintubation rate: a systematic review and meta-analysis of randomised studies of patients undergoing cardiothoracic surgery. Crit Care Resusc. 2013 Sep;15(3):220-7.

  PMID: 23944209 BACKGROUND

• Becher T, Vogt B, Kott M, Schadler D, Weiler N, Frerichs I. Functional Regions of Interest in Electrical Impedance Tomography: A Secondary Analysis of Two Clinical Studies. PLoS One. 2016 Mar 24;11(3):e0152267. doi: 10.1371/journal.pone.0152267. eCollection 2016.

  PMID: 27010320 BACKGROUND

• Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.

  PMID: 14693669 BACKGROUND

• Frerichs I, Dargaville PA, Dudykevych T, Rimensberger PC. Electrical impedance tomography: a method for monitoring regional lung aeration and tidal volume distribution? Intensive Care Med. 2003 Dec;29(12):2312-2316. doi: 10.1007/s00134-003-2029-z. Epub 2003 Oct 18.

  PMID: 14566457 BACKGROUND

• Costa EL, Chaves CN, Gomes S, Beraldo MA, Volpe MS, Tucci MR, Schettino IA, Bohm SH, Carvalho CR, Tanaka H, Lima RG, Amato MB. Real-time detection of pneumothorax using electrical impedance tomography. Crit Care Med. 2008 Apr;36(4):1230-8. doi: 10.1097/CCM.0b013e31816a0380.

  PMID: 18379250 BACKGROUND

• Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.

  PMID: 19255741 BACKGROUND

• Stankiewicz-Rudnicki M, Gaszynski T, Gaszynski W. Assessment of regional ventilation in acute respiratory distress syndrome by electrical impedance tomography. Anaesthesiol Intensive Ther. 2015;47(1):77-81. doi: 10.5603/AIT.2015.0007.

  PMID: 25751294 BACKGROUND

• Leonhardt S, Lachmann B. Electrical impedance tomography: the holy grail of ventilation and perfusion monitoring? Intensive Care Med. 2012 Dec;38(12):1917-29. doi: 10.1007/s00134-012-2684-z. Epub 2012 Sep 20.

  PMID: 22992946 BACKGROUND

• Karsten J, Grusnick C, Paarmann H, Heringlake M, Heinze H. Positive end-expiratory pressure titration at bedside using electrical impedance tomography in post-operative cardiac surgery patients. Acta Anaesthesiol Scand. 2015 Jul;59(6):723-32. doi: 10.1111/aas.12518. Epub 2015 Apr 13.

  PMID: 25867049 BACKGROUND

• Blankman P, Shono A, Hermans BJ, Wesselius T, Hasan D, Gommers D. Detection of optimal PEEP for equal distribution of tidal volume by volumetric capnography and electrical impedance tomography during decreasing levels of PEEP in post cardiac-surgery patients. Br J Anaesth. 2016 Jun;116(6):862-9. doi: 10.1093/bja/aew116.

  PMID: 27199318 BACKGROUND

• Tanaka H, Ortega NR, Galizia MS, Borges JB, Amato MB. Fuzzy modeling of electrical impedance tomography images of the lungs. Clinics (Sao Paulo). 2008 Jun;63(3):363-70. doi: 10.1590/s1807-59322008000300013.

  PMID: 18568247 BACKGROUND

• Kobylianskii J, Murray A, Brace D, Goligher E, Fan E. Electrical impedance tomography in adult patients undergoing mechanical ventilation: A systematic review. J Crit Care. 2016 Oct;35:33-50. doi: 10.1016/j.jcrc.2016.04.028. Epub 2016 May 3.

  PMID: 27481734 BACKGROUND

• Landoni G, Zangrillo A, Cabrini L. Noninvasive ventilation after cardiac and thoracic surgery in adult patients: a review. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):917-22. doi: 10.1053/j.jvca.2011.06.003. Epub 2011 Aug 11. No abstract available.

  PMID: 21835640 BACKGROUND

• Bordes J, Goutorbe P, Cungi PJ, Boghossian MC, Kaiser E. Noninvasive ventilation during spontaneous breathing anesthesia: an observational study using electrical impedance tomography. J Clin Anesth. 2016 Nov;34:420-6. doi: 10.1016/j.jclinane.2016.04.016. Epub 2016 Jun 16.

  PMID: 27687426 BACKGROUND

• Zhai J, Wei L, Huang B, Wang C, Zhang H, Yin K. Minimally invasive mitral valve replacement is a safe and effective surgery for patients with rheumatic valve disease: A retrospective study. Medicine (Baltimore). 2017 Jun;96(24):e7193. doi: 10.1097/MD.0000000000007193.

  PMID: 28614262 BACKGROUND

• Eronia N, Mauri T, Maffezzini E, Gatti S, Bronco A, Alban L, Binda F, Sasso T, Marenghi C, Grasselli G, Foti G, Pesenti A, Bellani G. Bedside selection of positive end-expiratory pressure by electrical impedance tomography in hypoxemic patients: a feasibility study. Ann Intensive Care. 2017 Dec;7(1):76. doi: 10.1186/s13613-017-0299-9. Epub 2017 Jul 20.

  PMID: 28730554 BACKGROUND

• Yildirim F, Esquinas AM, Glossop AJ. Noninvasive mechanical ventilation during spontaneous breathing anaesthesia: Can electrical impedance tomography be a useful bedside tool to titrate PEEP level? J Clin Anesth. 2017 Jun;39:106-107. doi: 10.1016/j.jclinane.2017.03.030. Epub 2017 Apr 4. No abstract available.

  PMID: 28494880 BACKGROUND

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Daniella C Brandão, PhD

  UFPE

  STUDY DIRECTOR

Central Study Contacts

Alita L Novaes, specialist

CONTACT

+5581991610199; alitanovaes@gmail.com

Wagner Leite, specialist

CONTACT

+5581981410170

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master´s program studant

Model Details: A parallel group study is a simple and commonly used clinical design which compares two treatments. Usually a test therapy is compared with a standard therapy. The allocation of subjects to groups is usually achieved by randomisation. The groups are typically named the treatment group and the control group. Parallel group designs do not require the same number of subjects in each group, although often similar numbers are observed. The design is commonly used in randomised controlled trials. Statistical analysis often boils down to a simple t-test of the between group difference in the outcome, which is usually a mean or a proportion.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 13, 2017
• Study Start: December 6, 2017
• Primary Completion: December 12, 2017
• Study Completion: February 28, 2018
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: march 2018
• Access Criteria: Date will be available by a USB pen drive copy by the researchers, including date relative to electrical impedance tomography and to bloog gases

Locations

BR (1)