Trial Outcomes & Findings for Effort of Breathing Guided Ventilator Protocol (NCT NCT02989246)
NCT ID: NCT02989246
Last Updated: 2024-10-30
Results Overview
The investigators will track the percentage of recommendations which are accepted by providers, as well as the reasons why recommendations were not accepted
COMPLETED
NA
32 participants
With each protocol recommendation, approximately every 4 hours during the course of mechanical ventilation (up to 28 days)
2024-10-30
Participant Flow
No exclusion of patients prior to assignment to the intervention.
Participant milestones
| Measure |
Intervention Arm
Ventilator management using the proposed protocol in both acute and weaning phases. Patients were managed according the the Ventilator protocol using the esophageal catheter
Ventilator protocol: Open loop ventilator management by a computer based protocol
Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing were used to guide the protocol recommendations
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=32 Participants
Ventilator management using the proposed protocol in both acute and weaning phases. Patients will be managed according the the Ventilator protocol using the esophageal catheter for the weaning phase
Ventilator protocol: Open loop ventilator management by a computer based protocol
Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations
|
|---|---|
|
Age, Continuous
|
100.7 months
n=32 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=32 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: With each protocol recommendation, approximately every 4 hours during the course of mechanical ventilation (up to 28 days)The investigators will track the percentage of recommendations which are accepted by providers, as well as the reasons why recommendations were not accepted
Outcome measures
| Measure |
Intervention Arm
n=32 Participants
Ventilator management using the proposed protocol in both acute and weaning phases. Patients were managed according the the Ventilator protocol using the esophageal catheter
Ventilator protocol: Open loop ventilator management by a computer based protocol
Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing were used to guide the protocol recommendations
|
|---|---|
|
Percentage of Protocol Recommendations Which Are Accepted by the Clinical Provider
|
76 percentage adherant
Interval 74.8 to 77.9
|
Adverse Events
Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Robinder Khemani, Associate Director of Research ACCM
Children's Hospital Los Angeles
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place