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Completed

NCT Number: NCT04171037

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen Therapy

Procedure

Receive oxygen via Optiflow THRIVE

Other names: supplemental oxygen therapy

Questionnaire Administration

Other

Ancillary studies

Optiflow THRIVE

Device

Oxygen Administration

Primary outcomes

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

    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.

Secondary outcomes

  1. Number of Desaturation Episode Events Per Patient/Surgical Procedure

    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.

  2. Number of BIS Episodes

    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.

  3. PACU Observation Time

    Time frame: up to 60 minutes after PACU admission

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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2019
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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