Cardiac Output, Low Clinical Trial
— CONNIEOfficial title:
The Performance of a Capnodynamic Method Compared to Transpulmonary Thermodilution in Open Abdominal Surgery
NCT number | NCT03444545 |
Other study ID # | CONNIE 1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 29, 2015 |
Est. completion date | December 31, 2018 |
Verified date | January 2019 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 31, 2018 |
Est. primary completion date | September 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Elective major abdominal surgery requiring advanced hemodynamic monitoring Exclusion Criteria: - Symptomatic coronary artery disease, chronic obstructive pulmonary disease with emphysema |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Stockholm County Council, Sweden |
Sweden,
Sander CH, Sigmundsson T, Hallbäck M, Sipmann FS, Wallin M, Oldner A, Björne 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. — View Citation
Sigmundsson TS, Öhman T, Hallbäck M, Redondo E, Sipmann FS, Wallin M, Oldner A, Hällsjö Sander C, Björne 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Changes in EPBF compared to changes in Cardiac output | Measurement of cardiac output and EPBF as described in Outcome 1 before and after hemodynamic changes. | Mean CO vs mean EPBF from zero to 4 hours perioperatively |
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