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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

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:

  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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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

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




Primary Outcome Measures :
  1. Right ventricular failure [ Time Frame: First 24 hours post cardiac surgery ]
  2. Pulmonary complications [ Time Frame: 30 days ]
    Composite outcome : pneumonia, prolonged mechanical ventilation (more than 24 hours) or clinically significant atelectasis (requiring > 2L O2).

  3. Acute Renal failure [ Time Frame: 30 days ]
    KDIGO : class I and more


Secondary Outcome Measures :
  1. Fluid balance [ Time Frame: First 24h ]
  2. Maximal blood lactate levels [ Time Frame: First 24h ]


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

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
Publications:

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