Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery

Not Applicable

• Conditions: Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency

• Registration Number: NCT04202575
• Lead Sponsor: Karolinska University Hospital

Brief Summary

The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnia and keeps sweep gas flow of the oxygenator constant during open heart surgery.

Detailed Description

Background: CO2-gas insufflation is used for continuous de-airing during open heart surgery. The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnea and keeps sweep gas flow of the oxygenator constant.

Methods: A separate small reservoir are used during CPB in addition to a standard large venous reservoir. The small reservoir receive drained wound blood and CO2-gas continuously via a suction drain (1 L/min) and handheld suction devices from the open surgical wound. CO2-gas is insufflated via a gas-diffuser in the open surgical wound at 10 L/min. During cross-clamping, gas and blood are either continuously drained to the standard large venous reservoir or not, every 5 minutes after steady state of PaCO2 is observed, after adjustment of sweep gas flow as necessary. Mean values for each setup (2-4 times) for each patient will be analyzed with Wilcoxon rank-sum test.

Study Timeline

• Study Start: 2019-08-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-15
• Study First Posted: 2019-12-17
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-19
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• adult patients undergoing open heart replacement of the aortic valve
• Use of perioperative cardiopulmonary bypass

Exclusion Criteria

• Denied participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Difference in PaCO2 (kPa)	At 5 minutes steady state

Secondary Outcome Measures

Name	Time	Method
Oxygenator sweep gas flow rate (L/min)	At 5 minutes steady state

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden