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

Hypercapnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757573
• Other study ID #: R16005
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Echocardiography
• Heart; Decompensation, Right Ventricle
• Hypercapnia

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital Heart Center	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tricuspid annular plane systolic excursion (TAPSE)	TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)	Change from baseline TAPSE at hypercarbia (in approximately 30 min)
Primary	Mean pulmonary artery pressure (MPAP)	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)