High-Flow Nasal Oxygen for Pediatric Hypoxia During Surgery

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if high-flow nasal cannula oxygen during surgery can prevent low oxygen levels in children under anesthesia. The treatment delivers oxygen through a small tube placed in the nose during the procedure. While this method has been used in adults, researchers seek to evaluate its effectiveness in children. Children under 18 scheduled for surgery with general anesthesia may qualify for this trial if their parents or guardians provide consent. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance surgical safety for children.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this high-flow nasal cannula technique is safe for pediatric patients?

Research has shown that high-flow nasal oxygen therapy is generally safe for children. In one study, 88% of children underwent airway surgery without interruptions while using this therapy, indicating good tolerance during procedures.

Another study found that although high-flow nasal oxygen therapy did not significantly reduce the need for extra oxygen during children's airway surgeries, it did not raise major safety concerns. This indicates the therapy was safe to use, even if it didn’t lessen the need for additional oxygen.

Overall, these studies suggest that high-flow nasal oxygen therapy is safe for children during surgery, helping procedures proceed smoothly without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional oxygen delivery methods for managing pediatric hypoxia during surgery, such as standard nasal cannulas or face masks, high-flow nasal oxygen (THRIVE) offers a unique approach by providing a continuous flow of oxygen at higher rates directly through a nasal cannula. This method can deliver oxygen at rates of 1-4L/kg/min, up to a maximum of 70L/min, allowing for better oxygenation and potentially reducing the risk of hypoxia. Researchers are excited about this technique because it can provide more precise control over oxygen concentration (ranging from 21% to 100%) tailored to the surgical conditions, which could lead to improved outcomes and a smoother recovery process for young patients.

What evidence suggests that high-flow nasal cannula is effective for preventing desaturation in pediatric surgery?

In this trial, participants in the intervention arm will receive high-flow nasal cannula (HFNC) therapy during surgery. Studies have shown that HFNC helps maintain steady oxygen levels and reduces the risk of oxygen desaturation, ensuring a higher minimum oxygen level in the blood. Research indicates that HFNC is as effective as other treatments, such as CPAP, in assisting children with conditions like MS-OSA. Although it hasn't consistently reduced the need for extra oxygen in some surgeries, HFNC remains a promising option for managing oxygen levels during operations. Overall, HFNC has successfully supported breathing during surgery, making it a valuable option for maintaining good oxygen levels in the body. ^{1 2 4 6 7}

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.

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?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12382278/

Effect of high-flow nasal oxygen therapy on perioperative ...

Compared with conventional oxygenation, HFNC use is associated with a lower risk of desaturation, higher minimum O2 saturation, and reduced need ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38788748/

High-flow nasal oxygen for children's airway surgery to ...

Nasal high-flow oxygen during tubeless upper airway surgery did not reduce the proportion of interruptions of the procedures for rescue oxygenation compared ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1389945725003120

Efficacy of high-flow nasal cannula therapy and its ...

Conclusions. HFNC is an alternative treatment option with comparable efficacy to CPAP in alleviating disease severity in paediatric patients with MS-OSA.

4.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2800430

Effect of Early High-Flow Nasal Oxygen vs Standard ...

Use of nasal high-flow oxygen therapy resulted in a median hospital stay of 1.77 days compared with 1.50 days in the standard oxygen therapy group.

5.

journals.lww.com

journals.lww.com/md-journal/fulltext/2022/07080/use_of_high_flow_nasal_oxygen_in_spontaneously.66.aspx

Use of high-flow nasal oxygen in spontaneously breathing...

High-flow nasal oxygen has been successfully used during perioperative periods, that is, for preoxygenation 14 and apneic oxygenation in ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2213260024001152

High-flow nasal oxygen for children's airway surgery to ...

The primary outcome of successful anaesthesia without interruption for tubeless airway surgery was achieved in 236 (88%) of 267 procedures on high-flow oxygen ...

7.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1714855

A Randomized Trial of High-Flow Oxygen Therapy in ...

High-flow oxygen therapy through a nasal cannula has been increasingly used in infants with bronchiolitis, despite limited high-quality evidence of its ...