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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02757573
Other study ID # R16005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date December 2019

Study information

Verified date April 2023
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography.


Description:

The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography. Investigators hypothesize that induced mild hypercarbia (PaCO2 7.5 kPa) cause elevated mean pulmonary arterial pressure and pulmonary vascular resistance, and this reflect to the right ventricle, both volume and function. And this right ventricle effect could be noticed by echocardiography.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - scheduled mitral valve prolapse repair surgery - able to give informed consent Exclusion Criteria: - preoperative right ventricular dysfunction or pulmonary hypertension - significant tricuspid regurgitation - congenital heart defect - ventricular dyssynchrony or wide QRS-complex on ECG (> 130 ms) - prior myocardial infarction (within tree months) or pericardial constriction - preoperative left ventricular (LV) dysfunction, i.e. LV ejection fraction under 40 % - if the scheduled repair by plastic procedure has been converted to mitral valve replacement

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hypercarbia
PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.

Locations

Country Name City State
Finland Tampere University Hospital Heart Center Tampere

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tricuspid annular plane systolic excursion (TAPSE) TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa) Change from baseline TAPSE at hypercarbia (in approximately 30 min)
Primary Mean pulmonary artery pressure (MPAP) MPAP will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa) Change from baseline MPAP at hypercarbia (in approximately 30 min)
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