Obstructive Sleep Apnea
Conditions
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.
Detailed description
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.
Interventions
PROCEDUREOxygen Therapy
Receive oxygen via Optiflow THRIVE
OTHERQuestionnaire Administration
Ancillary studies
DEVICEOptiflow THRIVE
Oxygen Administration
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| PACU Observation Time | up to 60 minutes after PACU admission | The length of time spent in the post-anesthesia care unit (PACU) in minutes. |
| 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 | The total number of episodes where the patient's oxygen saturation (SpO2) dropped to 92% or lower. |
| Number of BIS Episodes | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Optiflow™ THRIVE Treatment group will receive oxygen via Optiflow™ THRIVE | 50 |
| Control Group (Non-rebreather Facemask) Control group will receive 100% oxygen via a non-rebreather facemask | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 3 | 3 |
Baseline characteristics
| Characteristic | Control Group (Non-rebreather Facemask) | Total | Optiflow™ THRIVE |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 39 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 62 Participants | 30 Participants |
| Age, Continuous | 60.96 years STANDARD_DEVIATION 11.97 | 60.57 years STANDARD_DEVIATION 11.91 | 60.18 years STANDARD_DEVIATION 11.96 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 51 participants | 101 participants | 50 participants |
| Sex: Female, Male Female | 23 Participants | 45 Participants | 22 Participants |
| Sex: Female, Male Male | 28 Participants | 56 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 |
| other Total, other adverse events | 0 / 50 | 0 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 |
Outcome results
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.
Time frame: 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Optiflow™ THRIVE | Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure | 34 minutes | Standard Deviation 1.16 |
| Control Group (Non-rebreather Facemask) | Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure | 97 minutes | Standard Deviation 3.25 |
Secondary
Number of BIS Episodes
The total number of episodes where the bispectral index (BIS) value was 61 or higher, indicating inadequate sedation levels.
Time frame: 60-minute observation window starting from the initiation of the propofol infusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Optiflow™ THRIVE | Number of BIS Episodes | 2 Number of Episodes |
| Control Group (Non-rebreather Facemask) | Number of BIS Episodes | 4 Number of Episodes |
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.
Time frame: 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optiflow™ THRIVE | Number of Desaturation Episode Events Per Patient/Surgical Procedure | 7 Participants |
| Control Group (Non-rebreather Facemask) | Number of Desaturation Episode Events Per Patient/Surgical Procedure | 13 Participants |
Secondary
PACU Observation Time
The length of time spent in the post-anesthesia care unit (PACU) in minutes.
Time frame: up to 60 minutes after PACU admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Optiflow™ THRIVE | PACU Observation Time | 20 minutes |
| Control Group (Non-rebreather Facemask) | PACU Observation Time | 26 minutes |