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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02658006
Acronym
TechnoPeriOp
Enrollment
120
Registered
2016-01-18
Start date
2015-11-30
Completion date
2016-06-30
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, C.Surgical Procedure; Cardiac, Postoperative Complications, Respiratory Insufficiency, Right-Sided Heart Failure

Keywords

Near Infrared Spectroscopy, Ultrasonography, Hepatic vein Doppler, Portal vein Doppler, Lung ultrasound, Positive fluid balance, Mixed venous saturation

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.

Interventions

PROCEDURECardiac surgery

All cardiac surgery procedures

Sponsors

The Montreal Health Innovations Coordinating Center (MHICC)
CollaboratorOTHER
Medtronic - MITG
CollaboratorINDUSTRY
Montreal Heart Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Right ventricular failureFirst 24 hours post cardiac surgery
Pulmonary complications30 daysComposite outcome : pneumonia, prolonged mechanical ventilation (more than 24 hours) or clinically significant atelectasis (requiring \> 2L O2).
Acute Renal failure30 daysKDIGO : class I and more

Secondary

MeasureTime frame
Fluid balanceFirst 24h
Maximal blood lactate levelsFirst 24h

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026