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

Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency Clinical Trial

Official title:

Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery Using a Separate Reservoir for Suction of Blood From the Open Surgical Wound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04202575
• Other study ID #: 2018/1091-31
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 2020

Study information

• Verified date: December 2019
• Source: Karolinska University Hospital
• Contact: Jan van der Linden, MD, PhD
• Phone: +468-51770121
• Email: jan.vanderlinden[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients undergoing open heart replacement of the aortic valve

• Use of perioperative cardiopulmonary bypass

Exclusion Criteria:

• Denied participation in the study

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Tube clamping
Clamping of the tube between the additional and standard venous reservoir

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in PaCO2 (kPa)		At 5 minutes steady state
Secondary	Oxygenator sweep gas flow rate (L/min)		At 5 minutes steady state