Trial Outcomes & Findings for Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation (NCT NCT03093662)
NCT ID: NCT03093662
Last Updated: 2021-02-12
Results Overview
Measured by exhalation into sensor (Maxtec Max-250E)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
3 minutes after study start
Results posted on
2021-02-12
Participant Flow
Participant milestones
| Measure |
Ventilation With Nasal Cannula First, Then Without Nasal Cannula
First intervention: subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
Second intervention: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
|
Ventilation Without Nasal Cannula First, Then With Nasal Cannula
First intervention: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
Second intervention: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
|
|---|---|---|
|
First Intervention (3 Minutes)
STARTED
|
18
|
19
|
|
First Intervention (3 Minutes)
COMPLETED
|
18
|
19
|
|
First Intervention (3 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (5 Minutes)
STARTED
|
18
|
19
|
|
Washout Period (5 Minutes)
COMPLETED
|
18
|
19
|
|
Washout Period (5 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Minutes)
STARTED
|
18
|
19
|
|
Second Intervention (3 Minutes)
COMPLETED
|
18
|
19
|
|
Second Intervention (3 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ventilation With Nasal Cannula First
n=18 Participants
Non-invasive positive pressure ventilation with nasal cannula first followed by non-invasive positive pressure ventilation without nasal cannula.
Ventilation with nasal cannula: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
Ventilation without nasal cannula: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
|
Ventilation Without Nasal Cannula First
n=19 Participants
Non-invasive positive pressure ventilation without nasal cannula first followed by non-invasive positive pressure ventilation with nasal cannula.
Ventilation with nasal cannula: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
Ventilation without nasal cannula: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
19 Participants
n=19 Participants
|
37 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=37 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=18 Participants
|
6 Participants
n=19 Participants
|
11 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=18 Participants
|
13 Participants
n=19 Participants
|
26 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
19 participants
n=19 Participants
|
37 participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 3 minutes after study startPopulation: This was a cross-over study so ultimately all patients underwent both ventilation with nasal cannula and ventilation without nasal cannula; 18 underwent ventilation with nasal cannula first whereas the remaining 19 participants underwent ventilation without nasal cannula first. This design accounts for any combining of patients in analysis.
Measured by exhalation into sensor (Maxtec Max-250E)
Outcome measures
| Measure |
Ventilation With Nasal Cannula
n=37 Participants
Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
|
Ventilation Without Nasal Cannula
n=37 Participants
Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
|
|---|---|---|
|
End-tidal Oxygen
|
78.1 End tidal oxygen saturation percentage
Interval 75.5 to 80.8
|
78.6 End tidal oxygen saturation percentage
Interval 75.6 to 81.4
|
Adverse Events
Ventilation With Nasal Cannula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ventilation Without Nasal Cannula
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place