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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04202575
Enrollment
10
Registered
2019-12-17
Start date
2019-08-01
Completion date
2020-01-31
Last updated
2019-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDURETube clamping

Clamping of the tube between the additional and standard venous reservoir

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Denied participation in the study

Design outcomes

Primary

MeasureTime frame
Difference in PaCO2 (kPa)At 5 minutes steady state

Secondary

MeasureTime frame
Oxygenator sweep gas flow rate (L/min)At 5 minutes steady state

Countries

Sweden

Contacts

Primary ContactJan van der Linden, MD, PhD
jan.vanderlinden@ki.se+468-51770121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026