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

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

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.

Study Overview

• Status: Unknown
• Conditions: Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency
• Intervention / Treatment: Procedure: Tube clamping

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan van der Linden, MD, PhD; Phone Number: +468-51770121; Email: jan.vanderlinden@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Jan van der Linden, MD, PhD; Email: jan.vanderlinden@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: conventional setup; Blood and gas from the coronary and cardiotomy suction devices is continuously evacuated via the additional reservoir to the standard reservoir.
Experimental: 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.	Procedure: Tube clamping; Clamping of the tube between the additional and standard venous reservoir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in PaCO2 (kPa)	At 5 minutes steady state

Secondary Outcome Measures

Outcome Measure	Time Frame
Oxygenator sweep gas flow rate (L/min)	At 5 minutes steady state

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 15, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2018/1091-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If other researchers would show interest in the data, we may considered providing data on a group level. However, individual data cannot be made available due to the rules in the GDPR.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No