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

NCT ID: NCT02658006

Last Updated: 2016-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac surgical patients

Adult patients having a cardiac surgery at the Montreal Heart Institute

Cardiac surgery

Intervention Type PROCEDURE

All cardiac surgery procedures

Interventions

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Cardiac surgery

All cardiac surgery procedures

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Montreal Health Innovations Coordinating Center (MHICC)

OTHER

Sponsor Role collaborator

Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

Montreal Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Andre Denault

MD PhD FRCPC ABIM-CCM

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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André Y Denault, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

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Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 25432139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20027192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19151265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21257940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9475205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23267000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18184248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21050978 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15375480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24295842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23344830 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31609771 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30686306 (View on PubMed)

Other Identifiers

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2015-1903

Identifier Type: -

Identifier Source: org_study_id

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