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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

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.

Sponsor: Montreal Heart Institute

Current Primary Outcome:

  • Right ventricular failure [ Time Frame: 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).
  • Acute Renal failure [ Time Frame: 30 days ]
    KDIGO : class I and more


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fluid balance [ Time Frame: First 24h ]
  • Maximal blood lactate levels [ Time Frame: First 24h ]


Original Secondary Outcome: Same as current

Information By: Montreal Heart Institute

Dates:
Date Received: January 14, 2016
Date Started: November 2015
Date Completion:
Last Updated: September 12, 2016
Last Verified: September 2016