Trial Outcomes & Findings for Retrospective Review of Mechanically Ventilated Patients Using a Continuous Data Collection System. (NCT NCT02184208)
NCT ID: NCT02184208
Last Updated: 2018-02-05
Results Overview
Successful extubation without the use of noninvasive ventilation or requiring reintubation
Recruitment status
COMPLETED
Target enrollment
278 participants
Primary outcome timeframe
Within 24 hours of extubation
Results posted on
2018-02-05
Participant Flow
Participant milestones
| Measure |
Patient Categorization
We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.
|
|---|---|
|
Overall Study
STARTED
|
278
|
|
Overall Study
COMPLETED
|
222
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Review of Mechanically Ventilated Patients Using a Continuous Data Collection System.
Baseline characteristics by cohort
| Measure |
Patient Categorization
n=222 Participants
We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.
|
|---|---|
|
Age, Continuous
|
3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
222 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of extubationSuccessful extubation without the use of noninvasive ventilation or requiring reintubation
Outcome measures
| Measure |
Device Utlization Following Extubation
n=104 Participants
The ERT score predicted device utilization
|
Pulmonary Mechanics
n=222 Participants
Heart rate (HR), respiratory rate (RR), spontaneous respiratory rate (Spont. RR) and modified ventilation index (MVI) subcategory.
|
|---|---|---|
|
Successful Extubation
|
58 Participants
|
222 Participants
|
Adverse Events
Device Utlization Following Extubation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Pulmonary Mechanics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 20 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place