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N/A Completed N=175 Randomized Prevention

THRIVE Use in Pediatric Populations- Multi Site

Oxygen Deficiency · Desaturation of Blood · Hypoventilation · Anesthesia; Adverse Effect
Source: ClinicalTrials.gov NCT04322994 ↗
Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index — 18; 11; 13; 9 Participants — p=0.18

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.

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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