Endoscopic UltrasoundSuperNo2VANCT04306211
Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS
A study testing SuperNO2VA in people with Endoscopic Ultrasound, run by Indiana University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Ultrasound
- What is being tested?
- SuperNO2VA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Dec 2020to 30 Mar 2022
- 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
- Age 18 years of age or older
- Patients undergoing upper endoscopic ultrasound
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥35 kg/m2 or documented Obstructive Sleep Apnea
- Has provided written informed consent
Who cannot join
- Inpatient status
- Active Congestive Heart Failure Exacerbation
- Untreated ischemic heart disease
- Acute exacerbation of respiratory disorders, including COPD and asthma
- Emergent procedures
- Pregnancy
Show all 13Show fewer
- Previous enrollment in this study
- Inability to provide informed consent
- Additional medical testing planned for the same day
- History of allergic reaction to Propofol
- Tracheostomy
- Supra-glottic or sub-glottic tumor
- Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health University Hospital
Indianapolis, Indiana, 46202-5121
Indiana University Hospital
Indianapolis, Indiana, 46202-5121
About this study
Official title: Comparison of Oxygenation Between Nasal Positive Airway Pressure (PAP) Versus Standard Care During Propofol-based Sedation for Endoscopic Ultrasound in an Ambulatory Surgical Setting: a Prospective Randomized Control Trial
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.
Read the 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.
- Conditions
- Endoscopic Ultrasound
- Being tested
- SuperNO2VA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperNO2VADevice
SUPERNO2VA is nasal PAP device for oxygen delivery
| Study group | Role | What they receive |
|---|---|---|
| Facial mask | Active comparator | facial mask for oxygen delivery Receives: Device: SuperNO2VA |
| SuperNO2VA | Experimental | SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask Receives: Device: SuperNO2VA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefit of Nasal PAP Versus Nasal Administration of Oxygen
Compare the incidence, duration, and severity of oxygen desaturation
Measured: 60 minutes.
Secondary outcomes (3)
Total Amount of Propofol for Adequate Sedation
Compares amounts of Propofol for induction and entire procedure
Measured: 60 minutes.
Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)
Compare MOAAS immediately prior to intubation and during procedure
Measured: 120 minutes
Procedural Interruptions
Compare incidence, duration and reason for procedural interruptions
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start14 Dec 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Why it stopped: 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.
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.
- Other trials for Endoscopic UltrasoundStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Vyaire Medical
- Responsible party
- Principal investigator, John DeWitt, Indiana University
- Investigators
- John M DeWitt, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306211
- Sponsor's protocol ID
- 1810997768
- Acronym
- SuperNo2VA
- Status last verified
- Oct 2022
- First submitted
- 8 Mar 2020
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxygenation Between Nasal Positive Airway Pressure (PAP) Versus Standard Care During Propofol-based Sedation for Endoscopic Ultrasound in an Ambulatory Surgical Setting: a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04306211
- Acronym / sponsor ID
- SuperNo2VA / 1810997768
- Conditions
- Endoscopic Ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Vyaire Medical
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Posted 3 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Facial mask | Active comparator | Device: SuperNO2VAfacial mask for oxygen delivery |
| SuperNO2VA | Experimental | Device: SuperNO2VASuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years of age or older
- Patients undergoing upper endoscopic ultrasound
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥35 kg/m2 or documented Obstructive Sleep Apnea
- Has provided written informed consent
Key exclusion criteria (13 listed)
- Inpatient status
- Active Congestive Heart Failure Exacerbation
- Untreated ischemic heart disease
- Acute exacerbation of respiratory disorders, including COPD and asthma
- Emergent procedures
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 |
|---|---|---|
| SuperNO2VASUPERNO2VA is nasal PAP device for oxygen delivery | Device | Facial mask, SuperNO2VA |
Primary outcome
Benefit of Nasal PAP Versus Nasal Administration of Oxygen
Time frame: 60 minutes.
Compare the incidence, duration, and severity of oxygen desaturation
3 secondary outcomes
Total Amount of Propofol for Adequate Sedation
Time frame: 60 minutes.
Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)
Time frame: 120 minutes
Procedural Interruptions
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John M DeWitt, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperNO2VA in people with Endoscopic Ultrasound, run by Indiana University at 2 sites 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 Nov 2022). 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?
Benefit of Nasal PAP Versus Nasal Administration of Oxygen (time frame: 60 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2022.