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Device
On-Demand Oxygen Therapy for Patient Monitoring
N/A
Waitlist Available
Led By Kai Kuck, Ph.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure
Awards & highlights
Study Summary
This trialis investigating if giving oxygen only when patients breathe in is more effective than constant flow. It will measure the difference in oxygen saturation and end-tidal oxygen levels and end-tidal CO2 when oxygen delivery is off during expiration.
Who is the study for?
This trial is for relatively healthy patients undergoing sedation and pain relief during procedures, who are classified as ASA class I-III. It's not suitable for those with oxygen saturation below 93% on room air, severe lung or heart conditions, pregnant women, very high-risk surgery patients (ASA class IV+), short procedures under 20 minutes, or individuals under 18.Check my eligibility
What is being tested?
The study tests if an 'on-demand' oxygen delivery system that provides oxygen only when a patient inhales is more effective than traditional continuous-flow systems. The effectiveness will be measured by blood oxygen levels and the accuracy of CO2 monitoring when the flow is stopped during exhalation.See study design
What are the potential side effects?
While specific side effects aren't listed for this type of device trial, potential risks may include discomfort from wearing the device or inaccuracies in oxygen/CO2 level readings which could affect patient safety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
End-tidal Carbon Dioxide
End-tidal Oxygen
Oxygen Saturation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Only ArmExperimental Treatment3 Interventions
Two minutes: Intervention: Device: On Demand Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped
Two minutes intervention: Device: Traditional, Always-On, Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped
Repeat until the end of the surgical procedure
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,530 Total Patients Enrolled
Kai Kuck, Ph.D.Principal InvestigatorUniversity of Utah Department of Anesthesiology
2 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of severe lung or heart problems.My procedure is scheduled to last less than 20 minutes.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Only Arm
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 there available slots for enrolment in this scientific experiment?
"As indicated by clinicaltrials.gov, this investigation is no longer recruiting participants as it was last updated on October 31st 2022. However, there are two other trials that remain open for enrollment currently."
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