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
• Interventions: Procedure: Tube clamping

• 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

Arm && Interventions

Group	Intervention	Description
Intervention setup	Tube clamping	The connecting tube between the additional and standard venous reservoir is clamped. Thus, blood and gas from the coronary and cardiotomy suction devices are collected in the additional venous reservoir. During the intervention setup, the blood in the additional venous reservoir is only evacuated to the standard reservoir if the volume exceeded 800ml, and always with a remaining volume of 100 mL blood to keep the CO2-gas trapped in the additional venous reservoir.

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