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

NCT04171037 | Completed Results FDA Device

• 2 other identifiers: 2019-0348NCI-2019-07291
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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.

  60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes

Secondary Outcomes (3)

• 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

• Number of BIS Episodes

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

• PACU Observation Time

  up to 60 minutes after PACU admission

Study Arms (2)

Arm I (oxygen via Optiflow THRIVE)

EXPERIMENTAL

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.

Procedure: Oxygen Therapy; Other: Questionnaire Administration; Device: Optiflow THRIVE

Arm II (oxygen via non-rebreather mask)

ACTIVE COMPARATOR

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.

Procedure: Oxygen Therapy; Other: Questionnaire Administration

Interventions

Oxygen Therapy PROCEDURE

Receive oxygen via Optiflow THRIVE

Also known as: supplemental oxygen therapy

Arm I (oxygen via Optiflow THRIVE)

Questionnaire Administration OTHER

Ancillary studies

Arm I (oxygen via Optiflow THRIVE); Arm II (oxygen via non-rebreather mask)

Optiflow THRIVE DEVICE

Oxygen Administration

Arm I (oxygen via Optiflow THRIVE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center website

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Gang Zheng, MD
• Organization: The University of Texas MD Anderson Cancer Center

gzheng@mdanderson.org

(713) 563-2731

Study Officials

• Gang Zheng

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 20, 2019
• Study Start: October 4, 2019
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Locations

US (1)