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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tube clamping
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Denied participation in the study

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

conventional setup

Intervention setup

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Difference in PaCO2 (kPa)

Secondary Outcome Measures

Oxygenator sweep gas flow rate (L/min)

Full Information

First Posted
December 15, 2019
Last Updated
December 17, 2019
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04202575
Brief Title
Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional setup
Arm Type
No Intervention
Arm Description
Blood and gas from the coronary and cardiotomy suction devices is continuously evacuated via the additional reservoir to the standard reservoir.
Arm Title
Intervention setup
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tube clamping
Intervention Description
Clamping of the tube between the additional and standard venous reservoir
Primary Outcome Measure Information:
Title
Difference in PaCO2 (kPa)
Time Frame
At 5 minutes steady state
Secondary Outcome Measure Information:
Title
Oxygenator sweep gas flow rate (L/min)
Time Frame
At 5 minutes steady state

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan van der Linden, MD, PhD
Phone
+468-51770121
Email
jan.vanderlinden@ki.se
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan van der Linden, MD, PhD
Email
jan.vanderlinden@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
34363470
Citation
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.
Results Reference
derived

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

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