Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
NCT ID:
NCT02919267
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT02919267
Study Brief:
Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intra-pulmonary Pressure Measurements With Double-lumen Tube | For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean). | 0 | None | 0 | 10 | 0 | 10 | View |
| Intra-pulmonary Pressure Determination With Bronchial Blocker | For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean). | 0 | None | 0 | 12 | 0 | 12 | View |
| Gas Movement Quantification With Double-lumen Tube | For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume. | 0 | None | 0 | 13 | 0 | 13 | View |
| Gas Movement Quantification With Bronchial Blocker | For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume. | 0 | None | 0 | 14 | 0 | 14 | View |
Serious Events(If Any):
Other Events(If Any):