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

NCT ID: NCT04202575

Last Updated: 2019-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-01-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional setup

Blood and gas from the coronary and cardiotomy suction devices is continuously evacuated via the additional reservoir to the standard reservoir.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention setup

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.

Group Type: EXPERIMENTAL

Tube clamping

Intervention Type: PROCEDURE

Clamping of the tube between the additional and standard venous reservoir

Interventions

Tube clamping

Clamping of the tube between the additional and standard venous reservoir

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Denied participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jan van der Linden

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Jan van der Linden, MD, PhD

Role: CONTACT

jan.vanderlinden@ki.se

+468-51770121

Facility Contacts

Jan van der Linden, MD, PhD

Role: primary

jan.vanderlinden@ki.se

References

Nyman J, Holm M, Fux T, Sesartic V, Fredby M, Svenarud P, van der Linden J. Elimination of CO2 insufflation-induced hypercapnia in open heart surgery using an additional venous reservoir. Interact Cardiovasc Thorac Surg. 2021 Aug 18;33(3):483-488. doi: 10.1093/icvts/ivab082.

Reference Type: DERIVED

PMID: 34363470 (View on PubMed)

Other Identifiers

2018/1091-31

Identifier Type: -

Identifier Source: org_study_id