MedDataX Logo

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

Change from baseline to time of hospital discharge, no greater than 1 month

Results posted on

2017-08-21

Participant Flow

Participant milestones

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

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=5 Participants
28 Participants
n=7 Participants
55 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
10.31 months
n=5 Participants
11.36 months
n=7 Participants
10.8 months
n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
15 Participants
n=7 Participants
32 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
13 Participants
n=7 Participants
23 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
23 Participants
n=5 Participants
24 Participants
n=7 Participants
47 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
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Region of Enrollment
United States
27 participants
n=5 Participants
28 participants
n=7 Participants
55 participants
n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to time of hospital discharge, no greater than 1 month

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)

Outcome measures

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 hr

Actual length of stay in pediatric ICU from admission to discharge

Outcome measures

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

HFNC and External Nasal Dilator (END)

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

Dr. Janeth Ejike

Loma Linda University Children's Hospital

Phone: 9095584000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place