175 Participants Needed

High-Flow Nasal Oxygen for Pediatric Hypoxia During Surgery

Recruiting at 4 trial locations
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for children under 18 needing general anesthesia for surgeries or procedures. It's not suitable for pregnant individuals, those without parental consent, kids with certain nasal conditions (like fractures or obstructions), or if they have a tracheostomy tube. Emergent surgeries where HFNC could cause delays or increase aspiration risk are also excluded.

Inclusion Criteria

I am under 18 and will have surgery with general anesthesia.

Exclusion Criteria

Absence of parent or legal guardian able to provide written consent for study participation
Pregnancy
I need urgent surgery that could be delayed or risk increased by using a high-flow nasal cannula.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo their scheduled surgical or endoscopic procedure with high-flow nasal cannula applied prior to the start and removed following the procedure's conclusion

Less than 2 hours
1 visit (in-person)

Recovery

Participants recover from anesthesia and complete a brief questionnaire in the post-anesthesia recovery unit

Approximately 60 minutes
1 visit (in-person)

Follow-up

Participants are monitored for any adverse events and outcomes post-procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • THRIVE
Trial Overview The study tests the use of THRIVE - high-flow oxygen through a nasal cannula during surgery to see if it prevents low oxygen levels in pediatric patients under anesthesia and improves surgical outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

THRIVE is already approved in European Union, United States, Canada, Switzerland for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Lynparza for:
πŸ‡ΊπŸ‡Έ
Approved in United States as Lynparza for:
πŸ‡¨πŸ‡¦
Approved in Canada as Lynparza for:
πŸ‡¨πŸ‡­
Approved in Switzerland as Lynparza for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

UC Davis Children's Hospital

Collaborator

Trials
2
Recruited
3,600+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials
275
Recruited
5,182,000+

Nationwide Children's Hospital

Collaborator

Trials
354
Recruited
5,228,000+

Boston Children's Hospital

Collaborator

Trials
801
Recruited
5,584,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security