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Oxygen Delivery Device
Optiflow THRIVE for Obstructive Sleep Apnea
N/A
Recruiting
Led By Gang Zheng
Research Sponsored by M.D. Anderson Cancer Center
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 during a fixed 60-minute observation window during total intravenous anesthesia (tiva)
Awards & highlights
Study Summary
This trial is testing a new device that delivers oxygen to patients during surgery. The device may improve oxygen delivery and reduce breathing complications.
Who is the study for?
This trial is for patients with a SpO2 of at least 95% on room air, needing anesthesia without intubation for radiology procedures. Ideal candidates have a BMI ≥32 kg/m^2 or large neck circumference, or diagnosed moderate to severe sleep apnea. Not suitable for those with severe lung/heart disease, recent heart attacks, poor heart function, or emergency cases.Check my eligibility
What is being tested?
The study tests Optiflow THRIVE's effectiveness in delivering oxygen during total intravenous anesthesia in radiology procedures. It compares the high-flow humidified nasal oxygen delivery system against standard care to see if it reduces breathing complications.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the device and dryness or irritation inside the nose due to high-flow oxygen. There might also be risks associated with not receiving enough oxygen if the device doesn't work as intended.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during a fixed 60-minute observation window during total intravenous anesthesia (tiva)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during a fixed 60-minute observation window during total intravenous anesthesia (tiva)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total length of desaturation episodes (ToLDE) time (in minutes)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (oxygen via Optiflow THRIVE)Experimental Treatment3 Interventions
Patients receive 100% oxygen at a high flow rate via Optiflow THRIVE over 3 minutes prior to anesthetic induction and at a higher flow rate until the end of procedure.
Group II: Arm II (oxygen via non-rebreather mask)Active Control2 Interventions
Patients receive 100% oxygen at a lower flow rate via non-rebreather mask over 3 minutes prior to anesthetic induction and maintain the same flow rate until the end of procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxygen Therapy
2021
N/A
~10
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,197 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,401 Total Patients Enrolled
Gang ZhengPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need extra oxygen daily due to severe lung disease.I cannot have TIVA or my procedure does not involve TIVA.I had radiotherapy on my head or neck less than 6 months ago.Your oxygen level is 95% or higher when breathing normally.I need a tube inserted into my windpipe to help me breathe.I need IV anesthesia without a breathing tube and meet at least two other listed conditions.I have a serious heart condition, such as a past heart attack, weak heart muscle, or untreated heart failure.You have been classified as ASA physical status classification 5 by the American Society of Anesthesiologists.I have not had any emergency medical procedures recently.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (oxygen via Optiflow THRIVE)
- Group 2: Arm II (oxygen via non-rebreather mask)
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.
Is the enrollment period for this experiment still open?
"Affirmative, the clinicaltrials.gov page indicates that this trial is actively enrolling subjects. The initial listing was on October 4th 2019 and has recently been updated on December 8th 2022. One hundred individuals from a single research centre are needed for participation in the study."
Answered by AI
How many members of the general public have enrolled in this research project?
"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical study, which was first posted on October 4th 2019, is accepting new patients. Approximately 100 participants need to be recruited from 1 research site."
Answered by AI
Who else is applying?
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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