Trial Outcomes & Findings for Airway Pressure Release Ventilation in Acute Lung Injury (NCT NCT00750204)
NCT ID: NCT00750204
Last Updated: 2017-05-15
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
48 hours
Results posted on
2017-05-15
Participant Flow
2 participants were enrolled
Participant milestones
| Measure |
Airway Pressure Release Ventilation (APRV) First
Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude Airway Pressure Release Ventilation •Set FiO2 at 0.1 higher than the setting on conventional MV currently used •Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). •Respiratory rate (RR) to equal 60-65% of RR on conventional MV. •Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20. •Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW. •If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (min Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire
|
Conventional MV First
Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
Conventional MV: Low tidal-volume mechanical ventilation
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Airway Pressure Release Ventilation (APRV) First
Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude Airway Pressure Release Ventilation •Set FiO2 at 0.1 higher than the setting on conventional MV currently used •Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). •Respiratory rate (RR) to equal 60-65% of RR on conventional MV. •Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20. •Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW. •If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (min Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire
|
Conventional MV First
Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
Conventional MV: Low tidal-volume mechanical ventilation
|
|---|---|---|
|
Overall Study
study halted prematurely
|
1
|
1
|
Baseline Characteristics
Airway Pressure Release Ventilation in Acute Lung Injury
Baseline characteristics by cohort
| Measure |
APRV
n=1 Participants
Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
APRV: APRV Protocol
* Set FiO2 at 0.1 higher than the setting on conventional MV currently used
* Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).
* Respiratory rate (RR) to equal 60-65% of RR on conventional MV.
* Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.
* Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.
* If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire
|
Conventional MV
n=1 Participants
Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
Conventional MV: Low tidal-volume mechanical ventilation
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Data was not collected for this outcome measure, as the study was terminated prematurely.
Outcome measures
Outcome data not reported
Adverse Events
APRV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional MV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Roy Brower, M.D.
Johns Hopkins University School of Medicine
Phone: 1 (410) 614-6292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place