N/A
N=175
THRIVE Use in Pediatric Populations- Multi Site
Oxygen Deficiency · Desaturation of Blood · Hypoventilation · Anesthesia; Adverse Effect
Bottom Line
View on ClinicalTrials.gov: NCT04322994 ↗Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index — 18; 11; 13; 9 Participants — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transnasal Humidified Rapid-Insufflation Ventilatory Echange (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index |
18; 11; 13; 9; 5; 2 | 0.18 |
| PRIMARY Number of Participants With Desaturations <90% |
17; 11; 8; 9; 9; 2 | 0.26 |
| PRIMARY Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation |
19; 13; 3; 3; 16; 10 | 0.28 |
| SECONDARY Time-normalized Area Under Curve (AUC) of Desaturations <90% |
0.3; 0.28 | 0.88 |
| SECONDARY Number of Participants With Surgical Interruptions Due to Desaturation |
14; 7; 11; 5; 3; 2 | 0.14 |
| SECONDARY Minimum Oxygen Saturation as a Measure of Desaturation Severity |
2; 2; 3; 2; 12; 7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries
Exclusion Criteria
- Pregnancy
- Absence of parent or legal guardian able to provide written consent for study participation
- Anatomical or surgical contraindications (epistaxis, basilar skull fractures or abnormalities, nasal surgery or obstruction, nasal fractures, nasal vascular abnormalities), tracheostomy tube
- Emergent surgery for which application of HFNC might delay surgery or might result in increased aspiration risk.
Data sourced from ClinicalTrials.gov (NCT04322994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.