Back to resultsThe Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery
Primary Purpose
Heart; Decompensation, Right Ventricle, Echocardiography, Hypercapnia
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Hypercarbia
Sponsored by
About this trial
This is an interventional treatment trial for Heart; Decompensation, Right Ventricle
Eligibility Criteria
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
Sites / Locations
- Tampere University Hospital Heart Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypercarbia
Arm Description
Hypercarbia: PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.
Outcomes
Primary Outcome Measures
Tricuspid annular plane systolic excursion (TAPSE)
TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
Mean pulmonary artery pressure (MPAP)
MPAP will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
Secondary Outcome Measures
Full Information
NCT ID
NCT02757573
First Posted
April 20, 2016
Last Updated
April 22, 2023
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02757573
Brief Title
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery
Official Title
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery - Assessment With Pulmonary Arterial Catheter and Transesophageal Echocardiography Measurements
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart; Decompensation, Right Ventricle, Echocardiography, Hypercapnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypercarbia
Arm Type
Experimental
Arm Description
Hypercarbia: PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.
Intervention Type
Procedure
Intervention Name(s)
Hypercarbia
Intervention Description
PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.
Primary Outcome Measure Information:
Title
Tricuspid annular plane systolic excursion (TAPSE)
Description
TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
Time Frame
Change from baseline TAPSE at hypercarbia (in approximately 30 min)
Title
Mean pulmonary artery pressure (MPAP)
Description
MPAP will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
Time Frame
Change from baseline MPAP at hypercarbia (in approximately 30 min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kati Järvelä, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kati Rautaneva, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital Heart Center
City
Tampere
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery
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