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While there were no safety concerns, the choice of endoscopic ultrasound as part of the study design limited selection of patients. Additionally, inconsistent reliable inflation of the device was experienced during treatment.
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| Name | Class |
|---|---|
| Vyaire Medical | INDUSTRY |
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Randomized controlled single site study involves oxygenation, continuous positive airway pressure, and ventilation of subject via nasal mask and oxygenationvia closed facemask. The intervention of the study are delivery form of supplemental oxygen, bag-mask ventilation, and continuous nasal CPAP intraoperatively and in the post anesthesia care period.
124 patients with BMI> or equal to 35kg.m2 or documented Obstructive Sleep Apnea scheduled for an EUS with Propofol sedation will be randomized to CPAP vs nasal mask for oxygenation during their procedure. Patients will be monitored every 2 minutes during the procedure and in the recovery area until discharge. If patients have difficulty or refuse to wear the mask, 2 or more simultaneous or non-synchronous adverse events, change in heart rhythm or ST changes on EKG they will immediately changed to the other group. The ansethesiologist, gastroenterologist & patient will complete post-procedure questionnaires regarding their opinion of the oxygen delivery system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial mask | Active Comparator | facial mask for oxygen delivery |
|
| SuperNO2VA | Experimental | SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SuperNO2VA | Device | SUPERNO2VA is nasal PAP device for oxygen delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Benefit of Nasal PAP Versus Nasal Administration of Oxygen | Compare the incidence, duration, and severity of oxygen desaturation | 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Propofol for Adequate Sedation | Compares amounts of Propofol for induction and entire procedure | 60 minutes. |
| Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M DeWitt, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202-5121 | United States | ||
| Indiana University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Facial Mask | facial mask for oxygen delivery SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery |
| FG001 | SuperNO2VA | SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Facial Mask | facial mask for oxygen delivery SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery |
| BG001 | SuperNO2VA | SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Benefit of Nasal PAP Versus Nasal Administration of Oxygen | Compare the incidence, duration, and severity of oxygen desaturation | Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll. | Posted | 60 minutes. |
|
72 hours post procedure.
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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 | Facial Mask | facial mask for oxygen delivery SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John M. DeWitt, MD | Indiana University | 317-944-0980 | jodewitt@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2021 | Apr 5, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2021 | Jun 3, 2022 | SAP_001.pdf |
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Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
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Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
Compare MOAAS immediately prior to intubation and during procedure
| 120 minutes |
| Procedural Interruptions | Compare incidence, duration and reason for procedural interruptions | 60 minutes |
| Indianapolis |
| Indiana |
| 46202-5121 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Total Amount of Propofol for Adequate Sedation | Compares amounts of Propofol for induction and entire procedure | Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll. | Posted | 60 minutes. |
|
|
| Secondary | Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS) | Compare MOAAS immediately prior to intubation and during procedure | Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll. | Posted | 120 minutes |
|
|
| Secondary | Procedural Interruptions | Compare incidence, duration and reason for procedural interruptions | Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll. | Posted | 60 minutes |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | SuperNO2VA | SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery | 0 | 5 | 0 | 5 | 0 | 5 |
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