M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT04171037
This trial studies how well Optiflow THRIVE works in delivering oxygen to patients during total intravenous anesthesia while undergoing radiology procedures. The Optiflow THRIVE is an oxygen administration device that delivers high-flow and humidified oxygen through the nose. The Optiflow THRIVE device may improve oxygen delivery and reduce breathing complications.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
PRIMARY OBJECTIVE:
I. To investigate the performance of Optiflow THRIVE relative to Standard Non-Rebreathers in patients with high risk of difficult airway management undergoing interventional radiology procedures for the planning of future clinical studies.
SECONDARY OBJECTIVE:
I. To describe the episodes of hypoxia (defined by peripheral capillary oxygen saturation [SpO2] less than or equal to 92%) and the episodes of airway support which include: jaw thrust, chin lift or insertion of an airway supporting device, such as oral/nasal airway or supra airway device in order to recover the level of oxygenation above 92% associated with Optiflow THRIVE.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: 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.
After completion of study, patients are followed up at 15 minutes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive oxygen via Optiflow THRIVE
Other names: supplemental oxygen therapy
Ancillary studies
Oxygen Administration
Time frame: 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes
This measure is defined as the total length (in minutes) of all desaturation episodes that a patient experienced during a 60-minute observation window starting from the initiation of the propofol infusion. A desaturation episode is defined as a drop in oxygen saturation (SpO2) to 92% or lower.
Time frame: 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes
The total number of episodes where the patient's oxygen saturation (SpO2) dropped to 92% or lower.
Time frame: 60-minute observation window starting from the initiation of the propofol infusion.
The total number of episodes where the bispectral index (BIS) value was 61 or higher, indicating inadequate sedation levels.
Time frame: up to 60 minutes after PACU admission
The length of time spent in the post-anesthesia care unit (PACU) in minutes.
M.D. Anderson Cancer Center
Other
A Pilot Study of FDA Approved Optiflow™ THRIVE Versus Standard Non-Rebreathers in Patients With Potential High Risk of Airway Obstruction During Total Intravenous Anesthesia (TIVA) While Undergoing Interventional Radiology Procedures
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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