Evaluation of Monitoring TECHNOlogies in the PERI-OPerati... | NCT02658006

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

NCT02658006

Sponsor

Montreal Heart Institute

Status

Completed

Last Update Posted

Sep 13, 2016Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

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

Interventions

Cardiac surgery

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jan 14, 2016

First Submission Date that Met QC Criteria

Jan 14, 2016

First Posted Date

Jan 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2016

Last Update Posted Date

Sep 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andre Denault, MD PhD FRCPC ABIM-CCM, Montreal Heart InstitutePrincipal Investigator

Lead Sponsor

Montreal Heart InstituteOTHER

Collaborators

Name	Class
The Montreal Health Innovations Coordinating Center (MHICC)	OTHER
Medtronic - MITG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac surgical patients		Adult patients having a cardiac surgery at the Montreal Heart Institute	Procedure: Cardiac surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac surgery	Procedure	All cardiac surgery procedures	Cardiac surgical patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Fluid balance		First 24h
Maximal blood lactate levels		First 24h

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients having any cardiac surgery at the Montreal Heart Institute.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
André Y Denault, MD, PhD	Montreal Heart Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montreal Heart Institute		Montreal	Quebec	H1T 1C8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25432139	Background	Denault A, Lamarche Y, Rochon A, Cogan J, Liszkowski M, Lebon JS, Ayoub C, Taillefer J, Blain R, Viens C, Couture P, Deschamps A. Innovative approaches in the perioperative care of the cardiac surgical patient in the operating room and intensive care unit. Can J Cardiol. 2014 Dec;30(12 Suppl):S459-77. doi: 10.1016/j.cjca.2014.09.029. Epub 2014 Oct 5.
20027192

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures

ID	Term
D006333	Heart Failure
D058186	Acute Kidney Injury
D012131	Respiratory Insufficiency
D011183	Postoperative Complications