High-Flow Nasal Oxygen for Pediatric Hypoxia During Surgery

Recruiting at 4 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Anatomical contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Less than 2 hours

175 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Treatment subjects will undergo the scheduled procedure, with the difference being that a high-flow nasal cannula will be applied prior to the start of the procedure and removed following the procedure's conclusion. While applied, the cannula will deliver high- flow rate oxygen, air, or a mixture of variable oxygen concentration (21-100%) depending on the surgical conditions and requirements. The rate will be set at 1-4L/kg/min with a maximum of 70L/min. Participants in the treatment arm will then proceed to the recovery area as usual. Following recovery from anesthesia, a brief questionnaire will be provided to applicable patients or their parents / guardians / representatives. Intervention: Device: High-flow nasal cannula

Group II: Control Active Control 1 Intervention

Control subjects will undergo their scheduled procedure and recovery with the usual care. Following recovery from anesthesia, a brief questionnaire will be provided to applicable patients or their parents / guardians / representatives.

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

Approved in European Union as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Approved in Canada as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Approved in Switzerland as Lynparza for:

• Ovarian cancer
• Breast cancer
• Prostate cancer

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+