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 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
NCT ID:
NCT04663802
Description:
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
Frequency Threshold:
0
Time Frame:
All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Study:
NCT04663802
Study Brief:
Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Default Order Set | This arm will have the default order set implementation strategy Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values. | 264 | None | 24 | 956 | 0 | 956 | View |
| Standard of Care | This arm will have no interventions and standard of care practices will be in place. Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention | 844 | None | 95 | 2976 | 0 | 2976 | View |
| Physician-targeted Accountable Justification | This arm will have the physician-targeted accountable justification implementation strategy physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered. | 231 | None | 39 | 734 | 0 | 734 | View |
| Default Order Set + RT-targeted Accountable Justification | This arm will have the default order set and physician-targeted accountable justification Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values. RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy. | 367 | None | 42 | 1480 | 0 | 1480 | View |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the physician-targeted accountable justification order set and respiratory therapist-targeted accountable justification flowsheet physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered. RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy. | 394 | None | 64 | 1196 | 0 | 1196 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| life-threatening acidemia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| mortality within 24 hours | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| cardiac arrest within 24 hours | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):