Skip to main content
OpenTrials
Completed

NCT Number: NCT02658006

Evaluation of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

C.Surgical Procedure; Cardiac Acute Kidney Injury Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Renal Insufficiency Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Right-Sided Heart Failure Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

About this study

The study has 4 main objectives:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery

Procedure

All cardiac surgery procedures

Primary outcomes

  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 outcomes

  1. Fluid balance

    Time frame: First 24h

  2. Maximal blood lactate levels

    Time frame: First 24h

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TechnoPeriOp

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2016
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.