Evaluation of Monitoring TECHNOlogies in the PERI-OPerative Care of Cardiac Surgical Patients (TechnoPeriOp)

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ClinicalTrials.gov Identifier: NCT02658006

Recruitment Status : Completed

First Posted : January 18, 2016

Last Update Posted : September 13, 2016

Sponsor:

Collaborators:

The Montreal Health Innovations Coordinating Center (MHICC)

Medtronic - MITG

Information provided by (Responsible Party):

Andre Denault, Montreal Heart Institute

Study Description

Brief Summary:

The purpose of this prospective observational cohort study is to evaluate multimodal monitoring technologies in the perioperative care of cardiac surgical patients. Right ventricular pressure tracings, near infrared spectroscopy (NIRS) and transthoracic ultrasonography will be studied for their ability to detect and predict complications such as right ventricular failure, renal failure and respiratory failure.

Condition or disease	Intervention/treatment
C.Surgical Procedure; Cardiac Right-Sided Heart Failure Acute Kidney Injury Respiratory Insufficiency Postoperative Complications	Procedure: Cardiac surgery

Detailed Description:

The study has 4 main objectives:

To determine if right ventricular pressure tracings correlate with other indices of right ventricular failure and with positive fluid balance, renal failure and increased length of stay in the intensive care unit.
To determine the prevalence of portal vein pulsatility in the perioperative period and its association with right ventricular failure and positive fluid balance.
To determine if Near InfraRed Spectroscopy (NIRS) values correlate with mixed venous oxygen saturation (SvO2) and with poorer post-operative prognosis.
To determine the incidence, risk factors and prognosis of respiratory complications of cardiac surgery using transthoracic ultrasonography.

Study Design

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Study Type :	Observational
Actual Enrollment :	120 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Evaluation of Multimodal Monitoring Technologies in the Peri-operative Care of Cardiac Surgical Patients
Study Start Date :	November 2015
Actual Primary Completion Date :	June 2016
Actual Study Completion Date :	June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Genetic and Rare Diseases Information Center resources: Dextrocardia Situs Inversus

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cardiac surgical patients Adult patients having a cardiac surgery at the Montreal Heart Institute	Procedure: Cardiac surgery All cardiac surgery procedures

Outcome Measures

Primary Outcome Measures :

Right ventricular failure [ Time Frame: First 24 hours post cardiac surgery ]
Pulmonary complications [ Time Frame: 30 days ]
Composite outcome : pneumonia, prolonged mechanical ventilation (more than 24 hours) or clinically significant atelectasis (requiring > 2L O2).
Acute Renal failure [ Time Frame: 30 days ]
KDIGO : class I and more

Secondary Outcome Measures :

Fluid balance [ Time Frame: First 24h ]
Maximal blood lactate levels [ Time Frame: First 24h ]

Eligibility Criteria

Information from the National Library of Medicine

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

Study Population

Adult patients having any cardiac surgery at the Montreal Heart Institute.

Criteria

Inclusion Criteria:

Cardiac surgery performed at the Montreal Heart Institute
18 years old and older

Exclusion Criteria:

Urgent surgery
Pre-operative intra-aortic balloon pump, left ventricular assist device or ECMO
Heart transplant
Cirrhosis

Contacts and Locations

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): NCT02658006

Locations

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Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

Montreal Heart Institute

The Montreal Health Innovations Coordinating Center (MHICC)

Medtronic - MITG

Investigators

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Principal Investigator:	André Y Denault, MD, PhD	Montreal Heart Institute

More Information

Publications:

Denault A, Lamarche Y, Rochon A, Cogan J, Liszkowski M, Lebon JS, Ayoub C, Taillefer J, Blain R, Viens C, Couture P, Deschamps A. Innovative approaches in the perioperative care of the cardiac surgical patient in the operating room and intensive care unit. Can J Cardiol. 2014 Dec;30(12 Suppl):S459-77. doi: 10.1016/j.cjca.2014.09.029. Epub 2014 Oct 5. Review.

Prowle JR, Echeverri JE, Ligabo EV, Ronco C, Bellomo R. Fluid balance and acute kidney injury. Nat Rev Nephrol. 2010 Feb;6(2):107-15. doi: 10.1038/nrneph.2009.213. Epub 2009 Dec 22. Review.

Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92. Review.

McNaughton DA, Abu-Yousef MM. Doppler US of the liver made simple. Radiographics. 2011 Jan-Feb;31(1):161-88. doi: 10.1148/rg.311105093. Review. Erratum in: Radiographics. 2011 May-Jun;31(3):904.

Catalano D, Caruso G, DiFazzio S, Carpinteri G, Scalisi N, Trovato GM. Portal vein pulsatility ratio and heart failure. J Clin Ultrasound. 1998 Jan;26(1):27-31.

Zheng F, Sheinberg R, Yee MS, Ono M, Zheng Y, Hogue CW. Cerebral near-infrared spectroscopy monitoring and neurologic outcomes in adult cardiac surgery patients: a systematic review. Anesth Analg. 2013 Mar;116(3):663-76. doi: 10.1213/ANE.0b013e318277a255. Epub 2012 Dec 24. Review.

Nagdyman N, Ewert P, Peters B, Miera O, Fleck T, Berger F. Comparison of different near-infrared spectroscopic cerebral oxygenation indices with central venous and jugular venous oxygenation saturation in children. Paediatr Anaesth. 2008 Feb;18(2):160-6. doi: 10.1111/j.1460-9592.2007.02365.x.

Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039.

Weissman C. Pulmonary complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):185-211. Review.

Lobo V, Weingrow D, Perera P, Williams SR, Gharahbaghian L. Thoracic ultrasonography. Crit Care Clin. 2014 Jan;30(1):93-117, v-vi. doi: 10.1016/j.ccc.2013.08.002. Review.

Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cavayas YA, Eljaiek R, Rodrigue É, Lamarche Y, Girard M, Wang HT, Levesque S, Denault AY. Preoperative Diaphragm Function Is Associated With Postoperative Pulmonary Complications After Cardiac Surgery. Crit Care Med. 2019 Dec;47(12):e966-e974. doi: 10.1097/CCM.0000000000004027.

Eljaiek R, Cavayas YA, Rodrigue E, Desjardins G, Lamarche Y, Toupin F, Denault AY, Beaubien-Souligny W. High postoperative portal venous flow pulsatility indicates right ventricular dysfunction and predicts complications in cardiac surgery patients. Br J Anaesth. 2019 Feb;122(2):206-214. doi: 10.1016/j.bja.2018.09.028. Epub 2018 Nov 28.

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Responsible Party:	Andre Denault, MD PhD FRCPC ABIM-CCM, Montreal Heart Institute
ClinicalTrials.gov Identifier:	NCT02658006
Other Study ID Numbers:	2015-1903
First Posted:	January 18, 2016 Key Record Dates
Last Update Posted:	September 13, 2016
Last Verified:	September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Andre Denault, Montreal Heart Institute:


Near Infrared Spectroscopy Ultrasonography Hepatic vein Doppler Portal vein Doppler	Lung ultrasound Positive fluid balance Mixed venous saturation

Additional relevant MeSH terms:

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Respiratory Insufficiency Acute Kidney Injury Heart Failure Pulmonary Valve Insufficiency Dextrocardia Postoperative Complications Heart Diseases Cardiovascular Diseases Renal Insufficiency Kidney Diseases	Urologic Diseases Pathologic Processes Respiration Disorders Respiratory Tract Diseases Heart Valve Diseases Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities Situs Inversus

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