Trial Outcomes & Findings for Bi-Level Positive Airway Ventilation for Acute Chest Syndrome (NCT NCT01589926)
NCT ID: NCT01589926
Last Updated: 2018-12-11
Results Overview
Length of stay as measured by the time from initial diagnosis of ACS until meeting discharge criteria. It is anticipated length of stay will correlate to efficacy of treatment: shorter stay is theorized to indicate more efficient treatment.
TERMINATED
NA
3 participants
From diagnosis of ACS until meeting discharge criteria- Average 7 days.
2018-12-11
Participant Flow
Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.
Participant milestones
| Measure |
Bi-level Positive Airway Pressure
BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.
Bi-level positive airway pressure device: BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.
|
Sham CPAP
Physiologic CPAP initiated for at least 16 hours per day for a minimum of 48hrs.
Sham CPAP: Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bi-Level Positive Airway Ventilation for Acute Chest Syndrome
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: From diagnosis of ACS until meeting discharge criteria- Average 7 days.Population: Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.
Length of stay as measured by the time from initial diagnosis of ACS until meeting discharge criteria. It is anticipated length of stay will correlate to efficacy of treatment: shorter stay is theorized to indicate more efficient treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Diagnosis until discharge. Average 7 days.Population: Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Upon completion of intervention at 48hrs.Population: Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Diagnosis until discharge. Average 7 days.Population: Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48hrs after initiation of treatmentPopulation: Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48hrs after initiation of treatmentPopulation: Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48hrs after initiation of treatmentPopulation: Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.
Peripheral capillary oxygen saturation (SpO2) is an estimate of the amount of oxygen in the blood. It is the percentage of haemoglobin containing oxygen compared to the total amount of haemoglobin in the blood (i.e. oxygenated haemoglobin vs oxygenated and non-oxygenated haemoglobin).
Outcome measures
Outcome data not reported
Adverse Events
Bi-level Positive Airway Pressure
Sham CPAP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kerry Morrone, MD, Asst Prof of Pediatrics
Children's Hospital at Montefiore
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place