Clinical trial NCT02658006: Evaluation of Monitoring TECHNOlogies in the PERI-OPerative Care of Cardiac Surgical Patients
Official title: Evaluation of Multimodal Monitoring Technologies in the Peri-operative Care of Cardiac Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: C.Surgical Procedure; Cardiac
Right-Sided Heart Failure
Acute Kidney Injury
Respiratory Insufficiency
Postoperative Complications
Keywords: Near Infrared Spectroscopy
Ultrasonography
Hepatic vein Doppler
Portal vein Doppler
Lung ultrasound
Positive fluid balance
Mixed venous saturation
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: The Montreal Health Innovations Coordinating Center (MHICC)
name: Medtronic - MITG
First posted: 2016-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients having any cardiac surgery at the 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.

Eligibility criteria: 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

Primary outcomes:
measure: Right ventricular failure
timeFrame: First 24 hours post cardiac surgery
measure: Pulmonary complications
timeFrame: 30 days
measure: Acute Renal failure
timeFrame: 30 days
Secondary outcomes:
measure: Fluid balance
timeFrame: First 24h
measure: Maximal blood lactate levels
timeFrame: First 24h
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: André Y Denault, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cavayas YA, Eljaiek R, Rodrigue E, Lamarche Y, Girard M, Wang HT, Levesque S, Denault AY. Preoperative Diaphragm Function Is Associated With Postoperative Pulmonary Complications After Cardiac Surgery. Crit Care Med. 2019 Dec;47(12):e966-e974. doi: 10.1097/CCM.0000000000004027.
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