N/A
N=78
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures
Oxygen Deficiency · Desaturation of Blood · Hypoventilation · Anesthesia; Adverse Effect
Bottom Line
View on ClinicalTrials.gov: NCT03430206 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Surgical Interruptions — 0.645; 0.302 Interruptions — p=0.206
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-flow nasal cannula (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Surgical Interruptions |
0.645; 0.302 | 0.206 |
| SECONDARY Oxygen Desaturation Index |
1.09; 0.312 | 0.101 |
| SECONDARY Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%. |
0.536; 0.268 | 0.371 |
| SECONDARY Incidence of Oxygen Desaturation |
— | — |
| SECONDARY Incidence of Adverse Events |
0.183; 0.268 | 0.601 |
| SECONDARY End-Tidal Carbon Dioxide (ETCO2) |
51.6; 52.8 | 0.738 |
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 safely prevent desaturation events in children under anesthesia.
Eligibility Criteria
Inclusion Criteria
- Pediatric patients less than or equal to 18 years old undergoing general anesthesia for procedures or surgeries at Lucile Packard Children's Hospital.
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), papillomatosis, tracheostomy, emergent surgery for which application of HFNC might delay surgery or might result in increased aspiration risk.
Data sourced from ClinicalTrials.gov (NCT03430206). 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.