- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02757573
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery
April 22, 2023 updated by: Kati Järvelä, Tampere University Hospital
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery - Assessment With Pulmonary Arterial Catheter and Transesophageal Echocardiography Measurements
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
31
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
-
-
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Tampere, Finland, 33521
- Tampere University Hospital Heart Center
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypercarbia
Hypercarbia: PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.
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PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tricuspid annular plane systolic excursion (TAPSE)
Time Frame: Change from baseline TAPSE at hypercarbia (in approximately 30 min)
|
TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
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Change from baseline TAPSE at hypercarbia (in approximately 30 min)
|
Mean pulmonary artery pressure (MPAP)
Time Frame: Change from baseline MPAP at hypercarbia (in approximately 30 min)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
April 20, 2016
First Submitted That Met QC Criteria
April 29, 2016
First Posted (Estimate)
May 2, 2016
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 22, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R16005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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