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

NCT ID: NCT02757573

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Heart; Decompensation, Right Ventricle Echocardiography Hypercapnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypercarbia

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

Group Type EXPERIMENTAL

Hypercarbia

Intervention Type PROCEDURE

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

Interventions

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Hypercarbia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kati Järvelä

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kati Järvelä, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Kati Rautaneva, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital Heart Center

Tampere, , Finland

Site Status

Countries

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Finland

References

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Tujunen MLJ, Lahti J, Kiiski H, Kuitunen AH, Tuohinen SS, Rautaneva K, Jalkanen VL, Huhtala H, Jarvela KM. Right Ventricular Response to Hypercapnia After Mitral Valve Repair: A Hemodynamic Assessment. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70064. doi: 10.1111/aas.70064.

Reference Type DERIVED
PMID: 40490845 (View on PubMed)

Other Identifiers

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R16005

Identifier Type: -

Identifier Source: org_study_id

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