What side effects are associated with this type of intervention?

High-flow and humidified nasal oxygen delivery, such as the Optiflow THRIVE system, is generally well-tolerated but can cause nasal dryness, discomfort, and occasional nosebleeds. Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), which can lead to nasal congestion, dryness, and skin irritation from the mask. Other treatments like mandibular advancement devices may cause jaw discomfort and dental issues. Pharmacologic treatments are less common and can have side effects like dry mouth and insomnia.

What prior FDA approvals exist?

There is no specific mention of FDA approvals for high-flow and humidified nasal oxygen delivery systems like Optiflow THRIVE for the treatment of Obstructive Sleep Apnea (OSA) in the provided context. Generally, treatments for OSA include continuous positive airway pressure (CPAP) devices, oral appliances, and surgical interventions. Pharmacotherapy has not shown significant effectiveness and is considered adjunctive. Emerging evidence supports specific pharmacotherapy for particular cases, such as acetazolamide for high-altitude travelers.

What other types of research exist?

Promising novel alternatives to Optiflow THRIVE for Obstructive Sleep Apnea patients include: 1) Adaptive Servo-Ventilation (ASV), which adjusts pressure support based on detected airflow limitations, 2) Bilevel Positive Airway Pressure (BiPAP) with advanced algorithms for personalized therapy, and 3) Nasal High-Flow Therapy (NHFT) devices with integrated humidification and temperature control for enhanced comfort and efficacy.

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Oxygen Delivery Device

Optiflow THRIVE for Obstructive Sleep Apnea

N/A

Waitlist Available

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

Must not have

Significant pulmonary disease requiring supplemental oxygen in daily life (severe pulmonary fibrosis, severe chronic obstructive pulmonary disease, etc.)

TIVA is contraindicate or having a proposed procedure without TIVA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during a fixed 60-minute observation window during total intravenous anesthesia (tiva)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well Optiflow THRIVE works in delivering oxygen to patients at high risk of breathing problems during radiology procedures. The device provides a large amount of oxygen through the nose to help keep airways open and improve breathing.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need extra oxygen daily due to severe lung disease.

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I cannot have TIVA or my procedure does not involve TIVA.

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I need a tube inserted into my windpipe to help me breathe.

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I have a serious heart condition, such as a past heart attack, weak heart muscle, or untreated heart failure.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during a fixed 60-minute observation window during total intravenous anesthesia (tiva) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total length of desaturation episodes (ToLDE) time (in minutes)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Optiflow THRIVE

2019

N/A

~110

Oxygen Therapy

2019

N/A

~120

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), oral appliances, and high-flow nasal oxygen delivery systems like Optiflow THRIVE. CPAP works by providing a constant stream of air through a mask, which keeps the airway open during sleep, preventing apneas and improving oxygenation. Oral appliances reposition the jaw and tongue to maintain an open airway. High-flow nasal oxygen delivery systems, such as Optiflow THRIVE, provide humidified and heated oxygen at high flow rates through the nose, which can improve oxygenation and reduce breathing complications. These treatments are crucial for OSA patients as they help maintain airway patency, improve sleep quality, reduce daytime sleepiness, and lower the risk of associated cardiovascular and neurobehavioral complications.

The shifting relationship between weight and pediatric obstructive sleep apnea: A historical review.Obstructive sleep apnoea syndrome and endothelial function: potential impact of different treatment strategies-meta-analysis of prospective studies.Obstructive Sleep Apnea Treatment and Atrial Fibrillation: A Need for Definitive Evidence.