Under 18, any sex, with Oxygen Deficiency or Desaturation of Blood. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation IndexPrimary· Duration of surgery or procedure, which is generally less than 2 hours
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.
Any event
Group
Value
95% CI
Control
18
High-flow Nasal Cannula
11
1 event
Group
Value
95% CI
Control
13
High-flow Nasal Cannula
9
2+ events
Group
Value
95% CI
Control
5
High-flow Nasal Cannula
2
Number of Participants With Desaturations <90%Primary· Duration of surgery or procedure, which is generally less than 2 hours
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.
Any event
Group
Value
95% CI
Control
17
High-flow Nasal Cannula
11
1 event
Group
Value
95% CI
Control
8
High-flow Nasal Cannula
9
2+ events
Group
Value
95% CI
Control
9
High-flow Nasal Cannula
2
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline SaturationPrimary· Duration of surgery or procedure, which is generally less than 2 hours
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.
Any event
Group
Value
95% CI
Control
19
High-flow Nasal Cannula
13
1 event
Group
Value
95% CI
Control
3
High-flow Nasal Cannula
3
2+ events
Group
Value
95% CI
Control
16
High-flow Nasal Cannula
10
Time-normalized Area Under Curve (AUC) of Desaturations <90%Secondary· Duration of surgery or procedure, which is generally less than 2 hours
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.
Group
Value
95% CI
Control
0.3
± 0.91
High-flow Nasal Cannula
0.28
± 1.19
Number of Participants With Surgical Interruptions Due to DesaturationSecondary· Duration of surgery or procedure, which is generally less than 2 hours
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.
Any event
Group
Value
95% CI
Control
14
High-flow Nasal Cannula
7
1 event
Group
Value
95% CI
Control
11
High-flow Nasal Cannula
5
2+ events
Group
Value
95% CI
Control
3
High-flow Nasal Cannula
2
Minimum Oxygen Saturation as a Measure of Desaturation SeveritySecondary· Duration of surgery or procedure by second, which is generally less than 2 hours
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.
0-50% O2 saturation
Group
Value
95% CI
Control
2
High-flow Nasal Cannula
2
50-70% O2 saturation
Group
Value
95% CI
Control
3
High-flow Nasal Cannula
2
70-90% O2 saturation
Group
Value
95% CI
Control
12
High-flow Nasal Cannula
7
90-100% O2 saturation
Group
Value
95% CI
Control
54
High-flow Nasal Cannula
62
Sponsor's own description
THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) refers to the use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia. The use of high-flow nasal cannula oxygen supplementation during anesthesia for surgical procedures has been a recent development in the adult population, with limited data analyzing the pediatric population. This study will determine whether high flow nasal cannula oxygen supplementation during surgical or endoscopic procedures can prevent desaturation events in children under anesthesia and improve the outcomes of that surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 27 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04322994.