Obstructive Sleep ApneaNCT04171037
Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures
A study testing Oxygen Therapy, Questionnaire Administration and Optiflow THRIVE in people with Obstructive Sleep Apnea, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Oxygen Therapy, Questionnaire Administration and Optiflow THRIVE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2019to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Oxygen Therapy, Questionnaire Administration, Optiflow THRIVE
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen TherapyProcedure or surgery
Also called supplemental oxygen therapy
Receive oxygen via Optiflow THRIVE
Oxygen TherapyProcedure or surgery
Also called supplemental oxygen therapy
Receive oxygen via non-rebreather
Questionnaire AdministrationOther
Ancillary studies
Optiflow THRIVEDevice
Oxygen Administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Oxygen Therapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The total number of episodes where the patient's oxygen saturation (SpO2) dropped to 92% or lower.
Measured: 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.
Measured: 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.
Measured: up to 60 minutes after PACU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start4 Oct 2019
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gang Zheng, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171037
- Sponsor's protocol ID
- 2019-0348
- Other IDs
- NCI-2019-07291, 2019-0348
- Status last verified
- Jul 2025
- First submitted
- 19 Nov 2019
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 42251313
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04171037
- Acronym / sponsor ID
- 2019-0348
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Posted 24 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (oxygen via Optiflow THRIVE) | Experimental | Procedure: Oxygen Therapy, Other: Questionnaire Administration, Device: Optiflow THRIVEPatients 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 (oxygen via non-rebreather mask) | Active comparator | Procedure: Oxygen Therapy, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen TherapyAlso: supplemental oxygen therapyReceive oxygen via Optiflow THRIVE | Procedure or surgery | Arm I (oxygen via Optiflow THRIVE) |
| Oxygen TherapyAlso: supplemental oxygen therapyReceive oxygen via non-rebreather | Procedure or surgery | Arm II (oxygen via non-rebreather mask) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (oxygen via Optiflow THRIVE), Arm II (oxygen via non-rebreather mask) |
| Optiflow THRIVEOxygen Administration | Device | Arm I (oxygen via Optiflow THRIVE) |
Primary outcome
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.
3 secondary outcomes
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
Number of BIS Episodes
Time frame: 60-minute observation window starting from the initiation of the propofol infusion.
PACU Observation Time
Time frame: up to 60 minutes after PACU admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42251313Zheng 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.
- M D Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Zheng principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen Therapy, Questionnaire Administration and Optiflow THRIVE in people with Obstructive Sleep Apnea, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.