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

NCT02658006 | Completed

• 1 other identifier: 2015-1903
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

C.Surgical Procedure; Cardiac; Right-Sided Heart Failure; Acute Kidney Injury; Respiratory Insufficiency; Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Right ventricular failure

  First 24 hours post cardiac surgery

• Pulmonary complications

  Composite outcome : pneumonia, prolonged mechanical ventilation (more than 24 hours) or clinically significant atelectasis (requiring \> 2L O2).

  30 days

• Acute Renal failure

  KDIGO : class I and more

  30 days

Secondary Outcomes (2)

• Fluid balance

  First 24h

• Maximal blood lactate levels

  First 24h

Study Arms (1)

Cardiac surgical patients

Adult patients having a cardiac surgery at the Montreal Heart Institute

Procedure: Cardiac surgery

Interventions

Cardiac surgery PROCEDURE

All cardiac surgery procedures

Cardiac surgical patients

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Montreal Heart Institute: lead
• The Montreal Health Innovations Coordinating Center (MHICC): collaborator
• Medtronic - MITG: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (13)

• 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.

  PMID: 25432139 BACKGROUND

• 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.

  PMID: 20027192 BACKGROUND

• 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.

  PMID: 19151265 BACKGROUND

• 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.

  PMID: 21257940 BACKGROUND

• 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. doi: 10.1002/(sici)1097-0096(199801)26:13.0.co;2-l.

  PMID: 9475205 BACKGROUND

• 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.

  PMID: 23267000 BACKGROUND

• 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.

  PMID: 18184248 BACKGROUND

• 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.

  PMID: 21050978 BACKGROUND

• Weissman C. Pulmonary complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):185-211. doi: 10.1177/108925320400800303.

  PMID: 15375480 BACKGROUND

• 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.

  PMID: 24295842 BACKGROUND

• 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.

  PMID: 23344830 BACKGROUND

• Cavayas YA, Eljaiek R, Rodrigue E, 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.

  PMID: 31609771 DERIVED

• 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.

  PMID: 30686306 DERIVED

MeSH Terms

Conditions

Heart Failure; Acute Kidney Injury; Respiratory Insufficiency; Postoperative Complications

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• André Y Denault, MD, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD FRCPC ABIM-CCM

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 18, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)