Comparison · NCT00934596-sae
Lund De-airing vs Carbon-dioxide Insufflation: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Lund De-airing vs Carbon-dioxide Insufflation: serious adverse events. Trial comparisons, record NCT00934596-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00934596-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.278 | wilson | |
| Risk in group 2 | 0 | 0 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.278 | 0.278 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lund De-airing | Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent. | 0 | 10 | EG000 |
| Group 2 | Carbon-dioxide Insufflation | The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB. | 0 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Data was collected during the postoperative course when patient was still in ward (median time 7 Days).
Source ClinicalTrials.gov
Trial
- Title
- CO2 Versus Lund De-airing Technique in Heart Surgery
- NCT number
- NCT00934596
- Phases
- NA
- Conditions
- Aortic Valve Disorder
- Interventions
- Lund de-airing technique, carbon-dioxide insufflation
- Lead sponsor
- Lund University
- Results first posted
- 2013-12-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00934596?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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