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

Not Applicable

Completed

• Conditions: Hypercapnia; Heart; Decompensation, Right Ventricle; Echocardiography
• Interventions: Procedure: Hypercarbia

• Registration Number: NCT02757573
• Lead Sponsor: Tampere University Hospital

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-02
• Primary Completion: 2018-12
• Study Completion: 2019-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-22
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Tampere University Hospital Heart Center; 🇫🇮 Tampere, Finland