Trial Outcomes & Findings for THRIVE Use in Pediatric Populations- Multi Site (NCT NCT04322994)
NCT ID: NCT04322994
Last Updated: 2025-03-27
Results Overview
Oxygen desaturation index is defined as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds; data were recorded every 2 seconds while the procedure was being performed.
COMPLETED
NA
175 participants
Duration of surgery or procedure, which is generally less than 2 hours
2025-03-27
Participant Flow
Participants were recruited from six pediatric sites (Lucile Packard Children's Hospital, Cincinnati Children's hospital, Lurie Children's Hospital, University of Virginia Children's Hospital, Massachusetts Eye and Ear Infirmary, and Boston Children's Hospital between October 2020 and January 2024. The first participant was enrolled on October 21, 2020 and the last participant was enrolled in January 19, 2024.
Participant milestones
| Measure |
Control
Participants undergo their scheduled procedure and recovery with the usual care.
|
High-flow Nasal Cannula
Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
87
|
|
Overall Study
COMPLETED
|
71
|
73
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
THRIVE Use in Pediatric Populations- Multi Site
Baseline characteristics by cohort
| Measure |
Control
n=71 Participants
Participants undergo their scheduled procedure and recovery with the usual care.
|
High-flow Nasal Cannula
n=73 Participants
Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.6 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
4.7 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
5.1 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multirace
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of surgery or procedure, which is generally less than 2 hoursPopulation: Participants who completed the protocol.
Oxygen desaturation index is defined as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds; data were recorded every 2 seconds while the procedure was being performed.
Outcome measures
| Measure |
Control
n=71 Participants
Participants undergo their scheduled procedure and recovery with the usual care.
|
High-flow Nasal Cannula
n=73 Participants
Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.
|
|---|---|---|
|
Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index
Any event
|
18 Participants
|
11 Participants
|
|
Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index
1 event
|
13 Participants
|
9 Participants
|
|
Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index
2+ events
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Duration of surgery or procedure, which is generally less than 2 hoursPopulation: Participants who completed the protocol.
Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed.
Outcome measures
| Measure |
Control
n=71 Participants
Participants undergo their scheduled procedure and recovery with the usual care.
|
High-flow Nasal Cannula
n=73 Participants
Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.
|
|---|---|---|
|
Number of Participants With Desaturations <90%
Any event
|
17 Participants
|
11 Participants
|
|
Number of Participants With Desaturations <90%
1 event
|
8 Participants
|
9 Participants
|
|
Number of Participants With Desaturations <90%
2+ events
|
9 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Duration of surgery or procedure, which is generally less than 2 hoursPopulation: Participants who completed the protocol.
Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed. Participants who experienced both a fall below 90% O2 and a 4% drop below baseline saturation are reported as having more than 1 event.
Outcome measures
| Measure |
Control
n=71 Participants
Participants undergo their scheduled procedure and recovery with the usual care.
|
High-flow Nasal Cannula
n=73 Participants
Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.
|
|---|---|---|
|
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation
Any event
|
19 Participants
|
13 Participants
|
|
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation
1 event
|
3 Participants
|
3 Participants
|
|
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation
2+ events
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Duration of surgery or procedure, which is generally less than 2 hoursPopulation: Participants who experienced desaturation less than 90%
Duration of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90% (in those participants who experienced desaturation less than 90%), normalized as area under the curve / total time.
Outcome measures
| Measure |
Control
n=17 Participants
Participants undergo their scheduled procedure and recovery with the usual care.
|
High-flow Nasal Cannula
n=11 Participants
Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.
|
|---|---|---|
|
Time-normalized Area Under Curve (AUC) of Desaturations <90%
|
0.3 % of blood oxygen saturation
Standard Error 0.91
|
0.28 % of blood oxygen saturation
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Duration of surgery or procedure, which is generally less than 2 hoursPopulation: Participants who completed the protocol.
Number of surgical interruptions due to desaturation defined by a pause in surgical procedures due to need to provide airway intervention to improve patient's oxygen saturation, normalized to case length. Airway interventions may include jaw thrust, bag mask ventilation, and/or endotracheal intubations.
Outcome measures
| Measure |
Control
n=71 Participants
Participants undergo their scheduled procedure and recovery with the usual care.
|
High-flow Nasal Cannula
n=73 Participants
Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.
|
|---|---|---|
|
Number of Participants With Surgical Interruptions Due to Desaturation
Any event
|
14 Participants
|
7 Participants
|
|
Number of Participants With Surgical Interruptions Due to Desaturation
1 event
|
11 Participants
|
5 Participants
|
|
Number of Participants With Surgical Interruptions Due to Desaturation
2+ events
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Duration of surgery or procedure by second, which is generally less than 2 hoursPopulation: Participants who completed the protocol.
Number of participants categorized by lowest oxygen saturation level during surgery (nadir). Lower saturation levels correspond to a lower level of oxygen in red blood cells.
Outcome measures
| Measure |
Control
n=71 Participants
Participants undergo their scheduled procedure and recovery with the usual care.
|
High-flow Nasal Cannula
n=73 Participants
Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.
|
|---|---|---|
|
Minimum Oxygen Saturation as a Measure of Desaturation Severity
0-50% O2 saturation
|
2 Participants
|
2 Participants
|
|
Minimum Oxygen Saturation as a Measure of Desaturation Severity
50-70% O2 saturation
|
3 Participants
|
2 Participants
|
|
Minimum Oxygen Saturation as a Measure of Desaturation Severity
70-90% O2 saturation
|
12 Participants
|
7 Participants
|
|
Minimum Oxygen Saturation as a Measure of Desaturation Severity
90-100% O2 saturation
|
54 Participants
|
62 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperativelyIncidence of gas pain or bloating as measured by post-operative survey
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperativelyIncidence of nasal irritation as measured by post-operative survey
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperativelyIncidence of sinus pressure and/or pain as measured by post-operative survey
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperativelyIncidence of headache as measured by post-operative survey
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperativelyOther adverse events as measured by post-operative survey
Outcome measures
Outcome data not reported
Adverse Events
Control
High-flow Nasal Cannula
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