Endoscopic Ultrasound
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESuperNO2VA
SUPERNO2VA is nasal PAP device for oxygen delivery
Sponsors
Vyaire Medical
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
Intervention model description
Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years of age or older 2. Patients undergoing upper endoscopic ultrasound 3. American Society of Anesthesiology (ASA) Physical Status I-III 4. BMI ≥35 kg/m2 or documented Obstructive Sleep Apnea 5. Has provided written informed consent
Exclusion criteria
1. Inpatient status 2. Active Congestive Heart Failure Exacerbation 3. Untreated ischemic heart disease 4. Acute exacerbation of respiratory disorders, including COPD and asthma 5. Emergent procedures 6. Pregnancy 7. Previous enrollment in this study 8. Inability to provide informed consent 9. Additional medical testing planned for the same day 10. History of allergic reaction to Propofol 11. Tracheostomy 12. Supra-glottic or sub-glottic tumor 13. Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Benefit of Nasal PAP Versus Nasal Administration of Oxygen | 60 minutes. | Compare the incidence, duration, and severity of oxygen desaturation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Propofol for Adequate Sedation | 60 minutes. | Compares amounts of Propofol for induction and entire procedure |
| Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS) | 120 minutes | Compare MOAAS immediately prior to intubation and during procedure |
| Procedural Interruptions | 60 minutes | Compare incidence, duration and reason for procedural interruptions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Facial Mask facial mask for oxygen delivery
SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery | 6 |
| 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 | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Facial Mask | Total | SuperNO2VA |
|---|---|---|---|
| Age, Continuous | 52.6 years | 54.55 years | 56.17 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 10 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 4 Participants |
| Region of Enrollment United States | 6 participants | 11 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Benefit of Nasal PAP Versus Nasal Administration of Oxygen
Compare the incidence, duration, and severity of oxygen desaturation
Time frame: 60 minutes.
Population: Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll.
Secondary
Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)
Compare MOAAS immediately prior to intubation and during procedure
Time frame: 120 minutes
Population: Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll.
Secondary
Procedural Interruptions
Compare incidence, duration and reason for procedural interruptions
Time frame: 60 minutes
Population: Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll.
Secondary
Total Amount of Propofol for Adequate Sedation
Compares amounts of Propofol for induction and entire procedure
Time frame: 60 minutes.
Population: Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll.