Trial Outcomes & Findings for Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis (NCT NCT02373683)
NCT ID: NCT02373683
Last Updated: 2022-03-02
Results Overview
Change in the respiratory assessment score from baseline (within 15 minutes of extubation) to 48 hours after extubation. The score ranges from 0 to 12, with higher scores indicating worsening respiratory distress.
TERMINATED
NA
10 participants
48 hours
2022-03-02
Participant Flow
Participant milestones
| Measure |
Vapotherm-Heliox
Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.
Vapotherm-Heliox: Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.
|
Standard Care
Care dictated by clinical team.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data was not collected or analyzed.
Baseline characteristics by cohort
| Measure |
Vapotherm-Heliox
n=6 Participants
Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.
Vapotherm-Heliox: Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.
|
Standard Care
n=4 Participants
Care dictated by clinical team.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex/Gender, Customized
|
0 Participants
Data was not collected or analyzed
|
0 Participants
Data was not collected or analyzed
|
0 Participants
Data was not collected or analyzed
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Primary diagnosis
|
0 Participants
Data was not collected or analyzed
|
0 Participants
Data was not collected or analyzed
|
0 Participants
Data was not collected or analyzed
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Study was terminated early. Data were not collected and results were not analyzed.
Change in the respiratory assessment score from baseline (within 15 minutes of extubation) to 48 hours after extubation. The score ranges from 0 to 12, with higher scores indicating worsening respiratory distress.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During hospitalization, typically 4 days to 2 weeksPopulation: Study was terminated early. Data were not collected and results were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During hospitalization, typically 4 days to 2 weeksPopulation: Study was terminated early. Data were not collected and results were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During hospitalization, typically 4 days to 2 weeksPopulation: Study was terminated early. Data were not collected and results were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During hospitalization, typically 4 days to 2 weeksPopulation: Study was terminated early. Data were not collected and results were not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Vapotherm-Heliox
Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place