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

M.D. Anderson Cancer Center108 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

108

Conditions

Obstructive Sleep Apnea

Interventions

Oxygen TherapyPROCEDURE

Receive oxygen via Optiflow THRIVE

Oxygen TherapyPROCEDURE

Receive oxygen via non-rebreather

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure

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

Secondary Outcomes

Number of Desaturation Episode Events Per Patient/Surgical Procedure

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 and continuing for 60 minutes

Number of BIS Episodes

The total number of episodes where the bispectral index (BIS) value was 61 or higher, indicating inadequate sedation levels.

Time frame: 60-minute observation window starting from the initiation of the propofol infusion.

PACU Observation Time

The length of time spent in the post-anesthesia care unit (PACU) in minutes.

Time frame: up to 60 minutes after PACU admission

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.