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Respiratory Support Device
High-Flow Nasal Oxygen for Pediatric Hypoxia During Surgery
N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Awards & highlights
Study Summary
This trial will study whether high-flow nasal cannula oxygen supplementation can help prevent desaturation events (a lack of oxygen in the blood) in children during surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from the nasal device, dryness or bleeding in the nose due to high airflow, and possible breathing difficulties if not properly monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am under 18 and will have surgery with general anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of surgery or procedure by second
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of surgery or procedure by second
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Group differences in oxygen desaturation index
Incidence of oxygen desaturation
Relative incidence of desaturations <90% or defined by a 5% fall from baseline if baseline saturation < 94%.
Secondary outcome measures
Duration and severity of desaturations <90%
Relative number and severity of airway interventions due to desaturation
Relative number of surgical interruptions due to desaturation
Other outcome measures
Gas pain or bloating
Headache
Nasal irritation
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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: ControlActive Control1 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.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,333,550 Total Patients Enrolled
UC Davis Children's HospitalUNKNOWN
1 Previous Clinical Trials
3,400 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
256 Previous Clinical Trials
5,187,380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need urgent surgery that could be delayed or risk increased by using a high-flow nasal cannula.I am under 18 and will have surgery with general anesthesia.I do not have any major nose or skull issues that prevent procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being accepted into this medical experiment?
"Data sourced from clinicaltrials.gov suggests that this experiment is no longer recruiting patients, having been fully launched on October 21st 2020 and most recently updated June 13th 2022. That being said, there are 184 other medical trials seeking participants at the moment."
Answered by AI
Could you indicate the number of healthcare sites conducting this trial in the city?
"Currently, there are 5 locations participating in this trial; Palo Alto, Charlottesville and Chicago being the main ones. Additionally, 2 other medical centres serve patients that cannot access the former cities. It is suggested to pick a clinical centre closest to you for easy travel arrangements should participation be accepted."
Answered by AI
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