Determining the effect of CO2 in reducing number of microemboli in open cardiac surgery

Insufflation effect on the number of microemboli detected by Transesophageal echocardiography on multi-organ function in cardiopulmonary bypass surgery: A single-blinded randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201205278860N3

Enrollment

Registered

2012-06-05

Start date

2012-06-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Disease. Rheumatic mitral valve diseases

Interventions

Intervention 1: Control Group: Routine mitral valve surgery with cardiopulmonary bypass. Intervention 2: Treatment group: CO2 is insufflated into the cardiothoracic wound with a recently described gas

Prevention

Control Group: Routine mitral valve surgery with cardiopulmonary bypass

Treatment group: CO2 is insufflated into the cardiothoracic wound with a recently described gas diffuser that provides an almost 100% CO2 atmosphere in the wound. The diffuser is placed 5 cm below the

Eligibility

Sex/Gender

All

Age

18 Years to 149 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All patients scheduled for single primary mitral valve surgery at Rajaee heart center, Tehran, Iran; all patients are first time candidates for cardiac surgery. Exclusion criteria: 1. Preoperative Cr > 2 2; Total respiratory disability; 3. Reoperation; 4. Concomitant surgical process; 5. Carotid stenosis > 70%; 6. Class IV NYHA; 7. Previous stroke or TIA; 8. Previous MI; 9. Aortic atherosclerosis with = 4mm thickening or mobile plaque in TEE; 10.Diabetes.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Number of microemboli in trans esophageal echocardiography. Timepoint: First 15 min after release of cross-clamp, last 10 minutes of CPB, 20 minutes after CPB. Method of measurement: Counting.	—

Secondary

Measure	Time frame
S-Troponin T. Timepoint: First day after operation. Method of measurement: Laboratory kit.;S- creatinin kinase. Timepoint: First day after operation. Method of measurement: Laboratory kit.;ECG change. Timepoint: ICU stay, day 5-7 after operation. Method of measurement: ECG device.;Neurologic function change. Timepoint: second day after operation. Method of measurement: Neurologic function test.;Creatinin change. Timepoint: Every day at ICU, every other day at ward. Method of measurement: Laboratory kit.	—

Measure

Time frame

S-Troponin T. Timepoint: First day after operation. Method of measurement: Laboratory kit.;S- creatinin kinase. Timepoint: First day after operation. Method of measurement: Laboratory kit.;ECG change. Timepoint: ICU stay, day 5-7 after operation. Method of measurement: ECG device.;Neurologic function change. Timepoint: second day after operation. Method of measurement: Neurologic function test.;Creatinin change. Timepoint: Every day at ICU, every other day at ward. Method of measurement: Laboratory kit.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Alireza Alizadeh Ghavidel

Rajaei Heart Center

aaghavidel@gmail.com, aghavidel@rhc.ac.ir+98 21 2392 2147

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026