N/A
N=108
Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT04171037 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure — 34; 97 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxygen Therapy (Procedure); Questionnaire Administration (Other); Optiflow THRIVE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure |
34; 97 | — |
| SECONDARY Number of Desaturation Episode Events Per Patient/Surgical Procedure |
7; 13 | — |
| SECONDARY Number of BIS Episodes |
2; 4 | — |
| SECONDARY PACU Observation Time |
20; 26 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04171037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.