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CompletedNCT02658006TechnoPeriOpUpdated Sep 13, 2016

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

An observational study in C.Surgical Procedure; Cardiac, Right-Sided Heart Failure and Acute Kidney Injury, sponsored by Montreal Heart Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-13.

Sponsored by Montreal Heart Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

The study has 4 main objectives:

  1. 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.
  2. To determine the prevalence of portal vein pulsatility in the perioperative period and its association with right ventricular failure and positive fluid balance.
  3. To determine if Near InfraRed Spectroscopy (NIRS) values correlate with mixed venous oxygen saturation (SvO2) and with poorer post-operative prognosis.
  4. To determine the incidence, risk factors and prognosis of respiratory complications of cardiac surgery using transthoracic ultrasonography.
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Conditions studied

  • 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
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Urgent surgery
  • Pre-operative intra-aortic balloon pump, left ventricular assist device or ECMO
  • Heart transplant
  • Cirrhosis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Cardiac surgical patients

    Adult patients having a cardiac surgery at the Montreal Heart Institute

    Procedure: Cardiac surgery

Interventions

  • ProcedureCardiac surgery

    All cardiac surgery procedures

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What researchers measure

Primary outcomes

  1. Right ventricular failure

    Time frame: First 24 hours post cardiac surgery

  2. Pulmonary complications

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

    Time frame: 30 days

  3. Acute Renal failure

    KDIGO : class I and more

    Time frame: 30 days

Secondary outcomes

  1. Fluid balance

    Time frame: First 24h

  2. Maximal blood lactate levels

    Time frame: First 24h

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Study locations

1 site
  • Montreal Heart Institute
    Montreal, Quebec H1T 1C8, Canada
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References and documents

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. PubMed 25432139 ↗
  • 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. PubMed 20027192 ↗
  • 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. PubMed 19151265 ↗
  • 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. Erratum In: Radiographics. 2011 May-Jun;31(3):904. PubMed 21257940 ↗
  • 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. PubMed 9475205 ↗
  • 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. PubMed 23267000 ↗
  • 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. PubMed 18184248 ↗
  • 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. PubMed 21050978 ↗
  • Weissman C. Pulmonary complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):185-211. doi: 10.1177/108925320400800303. PubMed 15375480 ↗
  • 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. PubMed 24295842 ↗
  • 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. PubMed 23344830 ↗
  • 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. PubMed 31609771 ↗
  • 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. PubMed 30686306 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02658006
Lead sponsor
Montreal Heart Institute
Collaborators
The Montreal Health Innovations Coordinating Center (MHICC), Medtronic - MITG
Responsible party
Andre Denault (MD PhD FRCPC ABIM-CCM, Montreal Heart Institute) — Principal investigator
First posted
Jan 18, 2016
Start date
Nov 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Sep 13, 2016

Study contacts

André Y Denault, MD, PhD
principal investigator · Montreal Heart Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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