Trial Outcomes & Findings for External Nasal Dilator and Oxygen Therapy in Respiratory Failure (NCT NCT02662387)
NCT ID: NCT02662387
Last Updated: 2017-08-21
Results Overview
Change of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status)
COMPLETED
NA
55 participants
Change from baseline to time of hospital discharge, no greater than 1 month
2017-08-21
Participant Flow
Participant milestones
| Measure |
High Flow Nasal Cannula (HFNC)
Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27
|
HFNC and External Nasal Dilator (END)
high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
External Nasal Dilator and Oxygen Therapy in Respiratory Failure
Baseline characteristics by cohort
| Measure |
High Flow Nasal Cannula (HFNC)
n=27 Participants
Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27
|
HFNC and External Nasal Dilator (END)
n=28 Participants
high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
10.31 months
n=99 Participants
|
11.36 months
n=107 Participants
|
10.8 months
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
28 participants
n=107 Participants
|
55 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to time of hospital discharge, no greater than 1 monthChange of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status)
Outcome measures
| Measure |
High Flow Nasal Cannula (HFNC)
n=27 Participants
Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Higher MBSS
|
HFNC and External Nasal Dilator (END)
n=28 Participants
high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Lower MBSS
|
|---|---|---|
|
Change of Respiratory Status Using the Modified Bronchiolitis Severity Score, in Children Using External Nasal Dilators as an Adjuvant to High Flow Nasal Cannula Oxygen Therapy Compared to Those Receiving High Flow Nasal Cannula Therapy Alone
|
1 number/score
Interval 0.0 to 15.0
|
10 number/score
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: From subject enrollment to hospital discharge, not >170 hrActual length of stay in pediatric ICU from admission to discharge
Outcome measures
| Measure |
High Flow Nasal Cannula (HFNC)
n=27 Participants
Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Higher MBSS
|
HFNC and External Nasal Dilator (END)
n=28 Participants
high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Lower MBSS
|
|---|---|---|
|
Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU
|
73.5 hours
Interval 55.5 to 162.0
|
93.5 hours
Interval 54.5 to 135.5
|
Adverse Events
High Flow Nasal Cannula (HFNC)
HFNC and External Nasal Dilator (END)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Janeth Ejike
Loma Linda University Children's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place