Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac

NCT01880684 | Completed

• 1 other identifier: 13-1437
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the correlation of capnography with non-invasive measurement of cardiac output with the FloTrac/EV1000 following a reversible fluid challenge, a passive leg raising maneuver, using thermodilution as the gold standard. The main hypothesis is a correlation of 0.8 between the increasing of ETCO2 and the increasing of ejection volume measured by FloTrac/EV1000 following a passive leg raising maneuver.

Conditions

Hypovolemia; Cardiac Output, High; Cardiac Output, Low

Keywords

Thermodilution; Blood Volume; Cardiac Output; Leg; Capnography; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Correlation between elevation in ETCO2 and cardiac output during a reversible fluid challenge, a passive leg raise

  Correlation of 0.8 between the increase of ETCO2 and the increase of ejection volume measured by FloTrac/EV1000 following a passive leg raising maneuver

  Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit

Secondary Outcomes (3)

• Correlation between changes in indexed cardiac output measured by Flotrac/EV1000 and by thermodilution during a reversible fluid challenge, a passive leg raise

  Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit

• Correlation between elevation in capnography and indexed cardiac output measured by thermodilution during a reversible fluid challenge, a passive leg raise

  Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit

• Correlation between changes in capnography and indexed cardiac output measured by Flotrac/EV1000 during a reversible fluid challenge, a passive leg raise

  Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit

Study Arms (1)

Passive Leg Rising

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of 18 years old or more presenting for cardiac or aortic surgery at the Montreal Heart Institute.

You may qualify if:

• years old or more who have cardiac or aortic surgery

You may not qualify if:

• Pacemaker
• Lower limb amputation or absence of lower limb
• Moderate tricuspid insufficiency
• Preoperative arrythmia or prolonged arrythmia during data measurements
• Moderate aortic regurgitation
• Known deep vein thrombosis
• Intra-aortic balloon pump

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

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MeSH Terms

Conditions

Hypovolemia; Cardiac Output, High; Cardiac Output, Low

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FRCPC ABIM-CCM

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 19, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

CA (1)