Continous Cardiac Output - Non-Invasive Evaluation (CONNIE)

NCT03444545 | Completed

• 1 other identifier: CONNIE 1
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The capnodynamic method non-invasively calculates effective pulmonary blood flow (EPBF) continuously during surgery. In this study EPBF is compared to cardiac output (CO) measured with Transpulmonary Thermodilution (TPTD) att baseline and during hemodynamic changes in patients scheduled for open abdominal surgery at the Karolinska University Hospital, Solna, Sweden.

Conditions

Cardiac Output, Low; Cardiac Output, High

Keywords

Cardiac output; Carbon dioxide; Intraoperative monitoring; Pulmonary blood flow

Outcome Measures

Primary Outcomes (1)

• Absolute values of EPBF compared to Cardiac output

  Mean cardiac output as measured with transpulmonary thermodilution compared to mean effective pulmonary blood flow measured with the capnodynamic method at the start of first thermodilution and during the time interval zero to 4 hours.

  Mean CO vs EPBF from zero to 4 hours perioperatively

Secondary Outcomes (1)

• Changes in EPBF compared to changes in Cardiac output

  Mean CO vs mean EPBF from zero to 4 hours perioperatively

Interventions

Capnodynamic method DEVICE

Expired carbon dioxide is measured with a mainstream infrared sensor (Capnostat-3, Respironics Inc, Wallingford, CT, USA) and gas flow analysed with the flow sensor incorporated in the ventilator (Servo-i, Maquet Critical Care, Solna, Sweden) which was connected to a computer where all the mathematical analysis is carried out with a software written in Matlab™ (The Mathworks Inc, Natick, MA, USA). Instead of a fixed ratio between inspiration and expiration, three breaths out of every nine are prolonged with a 3-4 seconds longer expiration creating small changes in end- expiratory CO2

Transpulmonary thermodilution DEVICE

Each cardiac output measurement comprises an average of three thermodilutions performed successively one after another. TPTD is performed with a PiCCO2 monitor (Pulsion Medical Systems SE, Feldkirchen, Germany)

Also known as: PiCCO

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 having major abdominal surgery requiring advanced hemodynamic monitoring

You may qualify if:

• Elective major abdominal surgery requiring advanced hemodynamic monitoring

You may not qualify if:

• Symptomatic coronary artery disease, chronic obstructive pulmonary disease with emphysema

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (3)

• Sigmundsson TS, Ohman T, Hallback M, Redondo E, Sipmann FS, Wallin M, Oldner A, Hallsjo Sander C, Bjorne H. Performance of a capnodynamic method estimating effective pulmonary blood flow during transient and sustained hypercapnia. J Clin Monit Comput. 2018 Apr;32(2):311-319. doi: 10.1007/s10877-017-0021-3. Epub 2017 May 11.

  PMID: 28497180 BACKGROUND

• Sander CH, Sigmundsson T, Hallback M, Sipmann FS, Wallin M, Oldner A, Bjorne H. A modified breathing pattern improves the performance of a continuous capnodynamic method for estimation of effective pulmonary blood flow. J Clin Monit Comput. 2017 Aug;31(4):717-725. doi: 10.1007/s10877-016-9891-z. Epub 2016 Jun 1.

  PMID: 27251701 BACKGROUND

• Sigmundsson TS, Ohman T, Hallback M, Suarez-Sipmann F, Wallin M, Oldner A, Hallsjo-Sander C, Bjorne H. Comparison between capnodynamic and thermodilution method for cardiac output monitoring during major abdominal surgery: An observational study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1242-1252. doi: 10.1097/EJA.0000000000001566.

  PMID: 34155171 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Cardiac Output, Low; Cardiac Output, High

Condition Hierarchy (Ancestors)

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

Study Officials

• Hakan Björne, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor in department of pharmacology and physiology

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 23, 2018
• Study Start: October 29, 2015
• Primary Completion: September 28, 2018
• Study Completion: December 31, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

SE (1)