Trial Outcomes & Findings for Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD (NCT NCT04274192)
NCT ID: NCT04274192
Last Updated: 2022-05-05
Results Overview
estimated using swing Edi
TERMINATED
NA
1 participants
15 minutes
2022-05-05
Participant Flow
Only one participant was enrolled. The study was subsequently stopped. Reasons: 1. Lengthy study recruitment pause due to COVID 2. Principal investigator left the institution. 3. Insufficient staff to revise protocol and continue study. 4. Continuation of study would require significant protocol revision due to flow/pressure/ventilator interactions for this trial.
Participant milestones
| Measure |
Synchronized HFNC First
Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
|
Continuous HFNC First
Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Synchronized HFNC First
Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
|
Continuous HFNC First
Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD
Baseline characteristics by cohort
| Measure |
Synchronized HFNC First
n=1 Participants
Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
|
Continuous HFNC First
Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 days
n=5 Participants
|
—
|
56 days
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
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=7 Participants
|
1 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=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutesPopulation: Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data.
estimated using swing Edi
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 minutesPopulation: Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data.
estimated by phase angle calculated by data obtained from respiratory inductance plethysmography bands
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 minutesPopulation: Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data.
as estimated using data from respiratory plethysmography bands
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 minutesPopulation: Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data.
the amount of oxygen patient requires during the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 minutesPopulation: Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data.
measured by pulse oximetry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 minutesPopulation: Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data.
using a transcutaneous oxygen monitor
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 minutesPopulation: Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data.
using a transcutaneous carbon dioxide monitor
Outcome measures
Outcome data not reported
Adverse Events
Synchronized HFNC First
Continuous HFNC First
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Synchronized HFNC First
n=1 participants at risk
Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
|
Continuous HFNC First
Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Study team error
|
100.0%
1/1 • Number of events 1 • Until the end of the treatment, approximately 1 day per subject
0 subjects were enrolled in the "continuous HFNC" arm, therefore 0 were at risk for SAEs, All-cause mortality, or Other AEs
|
—
0/0 • Until the end of the treatment, approximately 1 day per subject
0 subjects were enrolled in the "continuous HFNC" arm, therefore 0 were at risk for SAEs, All-cause mortality, or Other AEs
|
Additional Information
Dr. Sherry Courtney
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place