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

Completed

• Conditions: C.Surgical Procedure; Cardiac; Right-Sided Heart Failure; Acute Kidney Injury; Postoperative Complications; Respiratory Insufficiency
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT02658006
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac surgical patients	Cardiac surgery	Adult patients having a cardiac surgery at the Montreal Heart Institute

Primary Outcome Measures

Name	Time	Method
Right ventricular failure	First 24 hours post cardiac surgery
Pulmonary complications	30 days	Composite outcome : pneumonia, prolonged mechanical ventilation (more than 24 hours) or clinically significant atelectasis (requiring \> 2L O2).
Acute Renal failure	30 days	KDIGO : class I and more

Secondary Outcome Measures

Name	Time	Method
Maximal blood lactate levels	First 24h
Fluid balance	First 24h

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada