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Clinical Trials/NCT02757573
NCT02757573CompletedNot Applicable

The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery - Assessment With Pulmonary Arterial Catheter and Transesophageal Echocardiography Measurements

Tampere University Hospital1 site in 1 country31 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
31
Locations
1
Primary Endpoint
Tricuspid annular plane systolic excursion (TAPSE)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Hypercarbia

Experimental

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

Intervention: Hypercarbia (Procedure)

Outcomes

Primary Outcomes

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)

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kati Järvelä

MD, PhD

Tampere University Hospital

Study Sites (1)

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