Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Signed consent for the study
Patients with an SpO2 greater than or equal to 95% while breathing room air
Patients requiring total intravenous anesthesia (TIVA) but not tracheal intubation during the proposed procedure - PLUS, any of the 2 following criteria: Body mass index (BMI) greater than or equal to 32 kg/m^2, or neck circumference greater than or equal to 43 cm in a male and 41 cm in a female, or has been diagnosed with moderate to severe obstructive sleep apnea (OSA) with/without using a continuous positive airway pressure (CPAP) device
Full course head and neck radiotherapy less than or equal to 6 months (the peak onset time of acute facial and airway edema)

Exclusion Criteria

Significant pulmonary disease requiring supplemental oxygen in daily life (severe pulmonary fibrosis, severe chronic obstructive pulmonary disease, etc.)
Significant cardiac disease (including history of myocardial infarction [MI] with concurrent evidence of ischemic myocardial damage at the event, cardiomyopathy with impaired left ventricular ejection fraction to less than 50% or uncompensated congestive heart failure)
TIVA is contraindicate or having a proposed procedure without TIVA
Endotracheal intubation is required
American Society of Anesthesiologists (ASA) physical status classification 5
Patients who are non-English speaking
Emergency procedures

Primary Outcome Measures

Name	Time	Method
Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure	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.

Secondary Outcome Measures

Name	Time	Method
Number of Desaturation Episode Events Per Patient/Surgical Procedure	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.
Number of BIS Episodes	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.
PACU Observation Time	up to 60 minutes after PACU admission	The length of time spent in the post-anesthesia care unit (PACU) in minutes.