Obstructive Sleep Apnea, ObesityNCT05524220
Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction
A study testing SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) in people with Obstructive Sleep Apnea, Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity
- What is being tested?
- SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2022to 9 Aug 2023
- 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
- Patients undergoing colonoscopy
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea
Who cannot join
- Inpatient status
- Active Congestive Heart Failure Exacerbation
- Untreated ischemic heart disease
- Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
- Emergent procedures
- Pregnancy
Show all 15Show 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).
- Prisoners
- Unable to fit SuperNoVa
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction: a Prospective Randomized Controlled Trial.
The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).
- Conditions
- Obstructive Sleep Apnea, Obesity
- Being tested
- Standard care with a facemask., SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
- Keywords
- Obstructive Sleep Apnea, total IV anesthesia, obesity, colonoscopy, Nasal cpap
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care with a facemask.Device
The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)Device
The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard care with a facemask. | Active comparator | Not described Receives: Device: Standard care with a facemask. |
| Group B: SuperNO2VA™EtCO2 | Experimental | Not described Receives: Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Taken From Initiation of Induction to the First Airway Intervention
Measured: From Initiation of Induction to the First Airway Intervention (about 16 minutes)
Secondary outcomes (16)
Amount of Propofol Administered During Induction
Measured: Within 5 minutes of the start of anesthesia
Total Amount of Propofol Administered During the Procedure
Measured: during the procedure (about 45 minutes)
Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)
This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness
Measured: prior to endoscopic intubation,during the procedure
Time Taken From Induction to Endoscopic Insertion
Measured: within 10 minutes of start of sedation
Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient
Measured: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient
Measured: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Number of Participants Who Received Airway Maneuvers
Measured: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Time Taken for Airway Maneuvers
Measured: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Reason for Airway Maneuvers
Measured: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Time Taken for the Entire Procedure
Measured: from start of procedure to end of procedure (about 45 minutes)
Recovery Time as Assessed by the Time When Subject Was Ready for Discharge
Measured: at time of discharge( about one hour from end of procedure)
Recovery Time as Assessed by the Actual Time When Subject Was Discharged
Measured: at time of discharge( about one and a half hour from end of procedure)
Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)
This will be scored from 0-10, a higher score indicating more satisfaction
Measured: at time of discharge(about one hour from end of procedure)
Number of Participants That Tolerated the SuperNO2VA™EtCO2
Measured: from start of procedure to end of procedure (about 45 minutes)
Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)
This will be scored from 0-10, a higher score indicating more satisfaction
Measured: end of procedure (about 45 minutes from start)
Number of Participants That Had Incidences of Cardiac Complications
Measured: during the procedure (about 45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start19 Dec 2022
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
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 Obstructive Sleep Apnea, ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vyaire Medical
- Responsible party
- Principal investigator, Erikka L Washington, The University of Texas Health Science Center, Houston
- Investigators
- Erikka Washington, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524220
- Sponsor's protocol ID
- HSC-MS-22-0351
- Status last verified
- Apr 2025
- First submitted
- 29 Aug 2022
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction: a Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05524220
- Acronym / sponsor ID
- HSC-MS-22-0351
- Conditions
- Obstructive Sleep Apnea, Obesity
- Keywords
- Obstructive Sleep Apnea, total IV anesthesia, obesity, colonoscopy, Nasal cpap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Vyaire Medical
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard care with a facemask. | Active comparator | Device: Standard care with a facemask. |
| Group B: SuperNO2VA™EtCO2 | Experimental | Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing colonoscopy
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea
Key exclusion criteria (15 listed)
- Inpatient status
- Active Congestive Heart Failure Exacerbation
- Untreated ischemic heart disease
- Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (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 |
|---|---|---|
| Standard care with a facemask.The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) | Device | Group A: Standard care with a facemask. |
| SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) | Device | Group B: SuperNO2VA™EtCO2 |
Primary outcome
Time Taken From Initiation of Induction to the First Airway Intervention
Time frame: From Initiation of Induction to the First Airway Intervention (about 16 minutes)
16 secondary outcomes
Amount of Propofol Administered During Induction
Time frame: Within 5 minutes of the start of anesthesia
Total Amount of Propofol Administered During the Procedure
Time frame: during the procedure (about 45 minutes)
Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)
Time frame: prior to endoscopic intubation,during the procedure
Time Taken From Induction to Endoscopic Insertion
Time frame: within 10 minutes of start of sedation
Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Number of Participants Who Received Airway Maneuvers
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Time Taken for Airway Maneuvers
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Reason for Airway Maneuvers
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Time Taken for the Entire Procedure
Time frame: from start of procedure to end of procedure (about 45 minutes)
Recovery Time as Assessed by the Time When Subject Was Ready for Discharge
Time frame: at time of discharge( about one hour from end of procedure)
Recovery Time as Assessed by the Actual Time When Subject Was Discharged
Time frame: at time of discharge( about one and a half hour from end of procedure)
Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)
Time frame: at time of discharge(about one hour from end of procedure)
Number of Participants That Tolerated the SuperNO2VA™EtCO2
Time frame: from start of procedure to end of procedure (about 45 minutes)
Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)
Time frame: end of procedure (about 45 minutes from start)
Number of Participants That Had Incidences of Cardiac Complications
Time frame: during the procedure (about 45 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- 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.
Erikka Washington, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) in people with Obstructive Sleep Apnea, Obesity, run by The University of Texas Health Science Center, Houston at 1 site 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 3 inclusion and 15 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: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Mar 2025). 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?
Time Taken From Initiation of Induction to the First Airway Intervention (time frame: From Initiation of Induction to the First Airway Intervention (about 16 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 22 Apr 2025.