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

September 12, 2016 updated by: Andre Denault, Montreal Heart Institute

Evaluation of Multimodal Monitoring Technologies in the Peri-operative Care of Cardiac Surgical Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right ventricular failure
Time Frame: First 24 hours post cardiac surgery
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).
30 days
Acute Renal failure
Time Frame: 30 days
KDIGO : class I and more
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Fluid balance
Time Frame: First 24h
First 24h
Maximal blood lactate levels
Time Frame: First 24h
First 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

Medtronic - MITG
The Montreal Health Innovations Coordinating Center (MHICC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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