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Completed

NCT Number: NCT02757573

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

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.

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Key information

Conditions

Heart; Decompensation, Right Ventricle Echocardiography Hypercapnia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital Heart Center

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypercarbia

Procedure

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

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 2, 2016
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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