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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07291 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0348 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen Therapy | Procedure | Receive oxygen via Optiflow THRIVE |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes |
| Number of BIS Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Zheng | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42251313 | Derived | Zheng G, Hernandez M, Hagberg CA. Use of optiflow THRIVE high-flow nasal oxygen system versus a non-rebreather oxygen delivery device in patients with increased risk of airway obstruction in interventional radiology procedures: a randomized pilot study. BMC Anesthesiol. 2026 Jun 6. doi: 10.1186/s12871-026-03977-8. Online ahead of print. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center website | View source |
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A total of 114 patients were accrued, and 108 patients were randomized. Of the total number randomized, six patients were screen failures prior to the procedure and 1 patient had no follow-up measurements, leaving 101 patients deemed evaluable for the primary endpoint. This provided 50 patients on Optiflow THRIVE and 51 patients on Standard of Care.
The IR procedure daily schedule will be used for patient selection. Once eligibility of a study candidate has been identified, the study coordinator will be informed to start the patient interview and obtain written informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Optiflow™ THRIVE | Treatment group will receive oxygen via Optiflow™ THRIVE |
| FG001 | Control Group (Non-rebreather Facemask) | Control group will receive 100% oxygen via a non-rebreather facemask |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2021 |
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| Oxygen Therapy | Procedure | Receive oxygen via non-rebreather |
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| Questionnaire Administration | Other | Ancillary studies |
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| Optiflow THRIVE | Device | Oxygen Administration |
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The total number of episodes where the bispectral index (BIS) value was 61 or higher, indicating inadequate sedation levels. |
| 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. | up to 60 minutes after PACU admission |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Optiflow™ THRIVE | Treatment group will receive oxygen via Optiflow™ THRIVE |
| BG001 | Control Group (Non-rebreather Facemask) | Control group will receive 100% oxygen via a non-rebreather facemask |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | 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. | Posted | Mean | Standard Deviation | minutes | 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes |
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| Secondary | 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. | Posted | Count of Participants | Participants | 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes |
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| Secondary | Number of BIS Episodes | The total number of episodes where the bispectral index (BIS) value was 61 or higher, indicating inadequate sedation levels. | Posted | Median | Full Range | Number of Episodes | 60-minute observation window starting from the initiation of the propofol infusion. |
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| Secondary | PACU Observation Time | The length of time spent in the post-anesthesia care unit (PACU) in minutes. | Posted | Median | Full Range | minutes | up to 60 minutes after PACU admission |
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From Induction to 15 minutes after PACU arrival
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Optiflow™ THRIVE | Treatment group will receive oxygen via Optiflow™ THRIVE | 0 | 50 | 0 | 50 | 0 | 50 |
| EG001 | Control Group (Non-rebreather Facemask) | Control group will receive 100% oxygen via a non-rebreather facemask | 0 | 51 | 0 | 51 | 0 | 51 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gang Zheng, MD | The University of Texas MD Anderson Cancer Center | (713) 563-2731 | gzheng@mdanderson.org |
| Apr 3, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
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| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Between 18 and 65 years |
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| >=65 years |
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