Non-invasive Evaluation of Volume Status Using Exhaled Carbon Dioxide and Pulse Contour Analysis

April 14, 2018 updated by: Ingrid Elise Hoff, Oslo University Hospital

Non-invasive Volume Evaluation With Exhaled Carbon Dioxide and Pulse Contour Analysis (Nexfin)

The investigators hypothesize that changes in blood circulation can be reflected by exhaled CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The investigators want to explore changes in cardiac output (the amount of blood being pumped out of the heart each minute) in patients using different devices: an esophagus ultrasound device measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and exhaled carbondioxide in the patients' breath measured by the ventilator.

The investigators investigate patients after bypass surgery or heart valve replacement, and induce changes in cardiac output with passive leg raise or ventricular pacing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Measurements with the finger cuff (pulse contour analyses) were aborted due to technical difficulties.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0454
        • Oslo University Hospital, Ullevål

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons 18 years or older scheduled to undergo arteriocoranary bypass surgery or aortic valve replacement.

Exclusion Criteria:

  • Esophageal pathology, EF <40%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comparing cardiac output changes

Explore the relationship between changes in cardiac output measured with eosophagal Doppler, the volume-clamp-method and exhaled CO2 during ventricular pacing and passive leg raise.

Measurements with the volume-clamp-method were aborted due to technological difficulties.
Other: Ventricular pacing and passive leg raise
Ventricular pacing and passive leg raise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in cardiac output
Time Frame: 5 Minutes
5 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

The Norwegian Air Ambulance Foundation

Investigators

  • Study Chair: Leiv Arne Rosseland, MD, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 23, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 14, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013/1605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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