The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery

Sponsor
Tampere University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02757573
Collaborator
(none)
31
1
1
80
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hypercarbia
N/A

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
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery - Assessment With Pulmonary Arterial Catheter and Transesophageal Echocardiography Measurements
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hypercarbia

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

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

Outcome Measures

Primary Outcome Measures

  1. Tricuspid annular plane systolic excursion (TAPSE) [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)

  2. Mean pulmonary artery pressure (MPAP) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tampere University Hospital Heart Center Tampere Finland 33521

Sponsors and Collaborators

  • Tampere University Hospital

Investigators

  • Principal Investigator: Kati Järvelä, MD, Tampere University Hospital
  • Principal Investigator: Kati Rautaneva, MD, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kati Järvelä, MD, PhD, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT02757573
Other Study ID Numbers:
  • R16005
First Posted:
May 2, 2016
Last Update Posted:
Apr 9, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 9, 2021