Trial · NCT00934596

CO2 Versus Lund De-airing Technique in Heart Surgery

NCT00934596, Not applicable, Completed, Lund University; results first posted 2013-12-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. CO2 Versus Lund De-airing Technique in Heart Surgery. Trials, record NCT00934596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00934596

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: CO2 Versus Lund De-airing Technique in Heart Surgery
NCT number: NCT00934596
Status: Completed
Phases: Not applicable
Enrollment: 20 participants, actual
Lead sponsor: Lund University
Conditions: Aortic Valve Disorder
Interventions: Lund de-airing technique, carbon-dioxide insufflation
First posted: 2009-07-08
Last updated: 2013-12-04
Results first posted: 2013-12-04
Limitations and caveats: This study included a total of 20 patients randomized to one of two groups with ten patients in each arms. The small number of study objects might be a potential limitation.

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	Before cardiac ejection	The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Primary	Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	After cardiac ejection	The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Primary	Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	During 10 minutes after cardiopulmonary bypass	The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Primary	Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).	0-3 minutes after end of cardiopulmonary bypass	Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
Primary	Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).	3-6 minutes after end of cardiopulmonary bypass	Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
Primary	Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).	6-10 minutes after end of cardiopulmonary bypass	Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
Secondary	Total Time Required for De-airing	After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes	The total de-airing time as measured in minutes.
Secondary	De-airing Time Before Cardiac Ejection	Measured during intraoperative course	Time in minutes starting at t1 (removal of aortic cross clamp) and ending at t2 (beginning of cardiac ejection).
Secondary	De-airing Time After Cardiac Ejection	During de-airing procedure	The duration in minutes of the period after cardiac ejection to finished de-airing procedure.
Secondary	Oxygenator Gas Flow at 45 Minutes of CPB	Intraoperative	The amount of carbon dioxide gas flow through the oxygenator was measured and compared between groups.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	Before cardiac ejection		Air Microemboli	MEAN
SECONDARY	Total Time Required for De-airing	After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes		Minutes	MEDIAN
SECONDARY	De-airing Time Before Cardiac Ejection	Measured during intraoperative course		minutes	MEDIAN
PRIMARY	Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	After cardiac ejection		Air Microemboli	MEAN
SECONDARY	De-airing Time After Cardiac Ejection	During de-airing procedure		minutes	MEDIAN
SECONDARY	Oxygenator Gas Flow at 45 Minutes of CPB	Intraoperative		L/minute	MEDIAN
POST_HOC	Fraction of Morphologically Damaged Red Blood Cells as Assessed by Scanning Electron Microscopy Studies.	Pieces of tubing collected after weaning from cardiopulmonary bypass	Samples were collected from 5 participants in each Group (total of 10 participants). For each participant 4 pieces of tubing were collected (20 pieces in each Group, total 40 pieces). Samples were photographed. One photograph from each individual was randomly selected and studied by an investigator blinded to Group (total of 10 photographs).	Fraction of Damaged Red Blood Cells	MEAN
SECONDARY	pH at 45 Min of CPB	Intraoperative		units on a scale	MEDIAN
PRIMARY	Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	During 10 minutes after cardiopulmonary bypass		Air Microemboli	MEAN
PRIMARY	Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).	0-3 minutes after end of cardiopulmonary bypass	The number was determined before hand as per protocoll.	participants	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	Lund De-airing Technique	41	Standard Deviation 20	Air Microemboli
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	Carbon-dioxide Insufflation Technique	118	Standard Deviation 70	Air Microemboli
Total Time Required for De-airing	Lund De-airing Technique	9	Inter-Quartile Range 8 to 10	Minutes
Total Time Required for De-airing	Carbon-dioxide Insufflation Technique	15	Inter-Quartile Range 11 to 16	Minutes
De-airing Time Before Cardiac Ejection	Lund De-airing	6	Inter-Quartile Range 4 to 7	minutes
De-airing Time Before Cardiac Ejection	Carbon-dioxide Insufflation	7	Inter-Quartile Range 5 to 10	minutes
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	Lund De-airing Technique	28	Standard Deviation 19	Air Microemboli
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).	Carbon-dioxide Insufflation Technique	119	Standard Deviation 84	Air Microemboli
De-airing Time After Cardiac Ejection	Lund De-airing	3	Inter-Quartile Range 2 to 3	minutes
De-airing Time After Cardiac Ejection	Carbon-dioxide Insufflation	5	Inter-Quartile Range 4 to 8	minutes

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lund De-airing Technique	10
Overall Study	STARTED	Carbon-dioxide Insufflation Technique	10
Overall Study	COMPLETED	Lund De-airing Technique	10
Overall Study	COMPLETED	Carbon-dioxide Insufflation Technique	10
Overall Study	NOT COMPLETED	Lund De-airing Technique	0
Overall Study	NOT COMPLETED	Carbon-dioxide Insufflation Technique	0

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Postoperative neurological dysfunction	Nervous system disorders	Lund De-airing	1	10	1
other	Postoperative neurological dysfunction	Nervous system disorders	Carbon-dioxide Insufflation	1	10	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lund De-airing
Total, all-cause mortality	Carbon-dioxide Insufflation
Total, other adverse events	Lund De-airing	1	10
Total, other adverse events	Carbon-dioxide Insufflation	1	10
Total, serious adverse events	Lund De-airing	0	10
Total, serious adverse events	Carbon-dioxide Insufflation	0	10

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20817209	DERIVED	PubMed
23246060	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lund De-airing Technique vs Carbon-dioxide Insufflation Technique: Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).	Trial comparisons
Lund De-airing Technique vs Carbon-dioxide Insufflation Technique: Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).	Trial comparisons
Lund De-airing Technique vs Carbon-dioxide Insufflation Technique: Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).	Trial comparisons
Lund De-airing vs Carbon-dioxide Insufflation: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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