Trial Outcomes & Findings for Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures (NCT NCT03430206)
NCT ID: NCT03430206
Last Updated: 2020-08-06
Results Overview
Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length.
COMPLETED
NA
78 participants
Duration of surgery (generally less than 2 hours)
2020-08-06
Participant Flow
Participant milestones
| Measure |
Standard of Care
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
22
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 participants in the THRIVE group were missing baseline values
Baseline characteristics by cohort
| Measure |
Standard of Care
n=18 Participants
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
n=21 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.1 years
STANDARD_DEVIATION 4.6 • n=18 Participants
|
6.6 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
5.5 years
STANDARD_DEVIATION 5.5 • n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=18 Participants
|
8 Participants
n=21 Participants
|
14 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=18 Participants
|
13 Participants
n=21 Participants
|
25 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=18 Participants
|
12 Participants
n=21 Participants
|
25 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=18 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Unknown/Unreported
|
3 Participants
n=18 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
21 Participants
n=21 Participants
|
39 Participants
n=39 Participants
|
|
Percent Oxygen Saturation
|
99.7 Percent Saturation
STANDARD_DEVIATION 0.6 • n=18 Participants • 3 participants in the THRIVE group were missing baseline values
|
99.3 Percent Saturation
STANDARD_DEVIATION 1.5 • n=18 Participants • 3 participants in the THRIVE group were missing baseline values
|
99.5 Percent Saturation
STANDARD_DEVIATION 1.2 • n=36 Participants • 3 participants in the THRIVE group were missing baseline values
|
PRIMARY outcome
Timeframe: Duration of surgery (generally less than 2 hours)Population: Participants who completed the protocol are included in the analysis
Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length.
Outcome measures
| Measure |
Standard of Care
n=18 Participants
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
n=21 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
|---|---|---|
|
Number of Surgical Interruptions
|
0.645 Interruptions
Interval 0.308 to 1.35
|
0.302 Interruptions
Interval 0.121 to 0.753
|
SECONDARY outcome
Timeframe: Duration of surgery (generally less than 2 hours)Population: Participants who completed the protocol are included in the analysis
Oxygen desaturation index is defined as the number of times a patient has a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds
Outcome measures
| Measure |
Standard of Care
n=18 Participants
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
n=21 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
|---|---|---|
|
Oxygen Desaturation Index
|
1.09 Events
Interval 0.415 to 2.86
|
0.312 Events
Interval 0.1 to 0.976
|
SECONDARY outcome
Timeframe: Duration of surgery (generally less than 2 hours)Population: Participants who completed the protocol are included in the analysis
Relative incidence of oxygen desaturation as measured by pulse oximetry by second adjusted for post surgical diagnosis
Outcome measures
| Measure |
Standard of Care
n=18 Participants
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
n=21 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
|---|---|---|
|
Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%.
|
0.536 Events
Interval 0.195 to 1.473
|
0.268 Events
Interval 0.087 to 0.826
|
SECONDARY outcome
Timeframe: Duration of surgery (generally less than 2 hours)Population: This outcome measure was removed from the analysis plan during the course of the study.
Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 hoursPopulation: Participants who completed the protocol are included in the analysis
Outcome measures
| Measure |
Standard of Care
n=18 Participants
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
n=21 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
|---|---|---|
|
Incidence of Adverse Events
|
0.183 Events
Interval 0.061 to 0.547
|
0.268 Events
Interval 0.107 to 0.672
|
SECONDARY outcome
Timeframe: Duration of surgery (generally less than 2 hours)Population: Participants who completed the protocol are included in the analysis
Ventilation was measured with transcutaneous carbon dioxide sensor
Outcome measures
| Measure |
Standard of Care
n=18 Participants
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
n=21 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
|---|---|---|
|
End-Tidal Carbon Dioxide (ETCO2)
|
51.6 mmHg
Interval 46.5 to 56.7
|
52.8 mmHg
Interval 48.2 to 57.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of surgery (generally less than 2 hours)Population: Participants who completed the protocol are included in the analysis
Location of lesion(s) according to post-surgical diagnosis
Outcome measures
| Measure |
Standard of Care
n=18 Participants
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
n=21 Participants
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
|---|---|---|
|
Post-surgical Diagnosis
Supraglottic
|
2 Participants
|
10 Participants
|
|
Post-surgical Diagnosis
Infraglottic
|
13 Participants
|
10 Participants
|
|
Post-surgical Diagnosis
Both Supraglottic and Infraglottic
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively.Incidence 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 postoperatively.Incidence 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 postoperatively.Incidence 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 postoperatively.Incidence 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 postoperatively.Other adverse events as measured by post-operative survey
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care
THRIVE
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=40 participants at risk
Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
|
THRIVE
n=38 participants at risk
Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • Up to 12 hours
|
5.3%
2/38 • Up to 12 hours
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/40 • Up to 12 hours
|
2.6%
1/38 • Up to 12 hours
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleeding
|
0.00%
0/40 • Up to 12 hours
|
2.6%
1/38 • Up to 12 hours
|
|
Gastrointestinal disorders
Emesis
|
2.5%
1/40 • Up to 12 hours
|
0.00%
0/38 • Up to 12 hours
|
|
Respiratory, thoracic and mediastinal disorders
Throat Pain
|
0.00%
0/40 • Up to 12 hours
|
5.3%
2/38 • Up to 12 hours
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Pain
|
2.5%
1/40 • Up to 12 hours
|
0.00%
0/38 • Up to 12 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place