Clinical trial NCT04171037: Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 outcomes:
measure: Total length of desaturation episodes (ToLDE) time (in minutes)
timeFrame: During a fixed 60-minute observation window during total intravenous anesthesia (TIVA)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gang Zheng
role: PRINCIPAL_INVESTIGATOR
References: