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Comparison · NCT02361944-sae

Normoxia vs Hyperoxia: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Normoxia vs Hyperoxia: serious adverse events. Trial comparisons, record NCT02361944-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02361944-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.080.04110.15wilson
Risk in group 20.110.06250.186wilson
Risk difference, group 1 minus group 2-0.03-0.1160.0546newcombe hybrid score
Risk ratio, group 1 over group 20.7270.3051.73log
Odds ratio, group 1 over group 20.7040.271.83log
Number needed to treat, for one fewer participant with a serious adverse event on Normoxia than on Hyperoxia33.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Normoxia
Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery.~Oxygen - normoxia: Titration of FIO2 to maintain normal hemoglobin oxygen saturation (95-97%)
8100EG000
Group 2Hyperoxia
Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery.~Oxygen - hyperoxia: Administration of 1.0 FIO2 during ventilation and 0.8 or above during cardiopulmonary bypass
11100EG001

Harm

What it counts
Total, serious adverse events
Time frame
baseline to one year following surgery

Source ClinicalTrials.gov

Trial

Title
Risk of Oxygen During Cardiac Surgery Trial
NCT number
NCT02361944
Phases
PHASE2, PHASE3
Conditions
Cardiac Surgery
Interventions
Oxygen - normoxia, Oxygen - hyperoxia
Lead sponsor
Vanderbilt University
Results first posted
2023-08-14

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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