Oxygen DesaturationNCT07515755
Supplemental Oxygen and Oxygen Desaturations in Colonoscopies
A study testing Breath-synchronized oxygen and CPAP in people with Oxygen Desaturation and Apnea (Central and Obstructive), run by University of Utah at 1 site in United States.
Trial summary
This study will compare apnea and oxygen desaturation events among various methods of supplemental oxygen delivery during procedural sedation in colonoscopy patients. The goals of the study are to track apnea (10 or more seconds without respiration) and oxygen desaturation (hemoglobin oxygen saturation less than 90%)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxygen Desaturation, Apnea (Central and Obstructive), Airway Obstruction
- What is being tested?
- Breath-synchronized oxygen and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient
- No life threatening conditions
- Undergoing colonoscopy procedures and receiving procedural sedation at the University of Utah Health clinic in South Jordan, Utah.
Who cannot join
- Inability/refusal of subject to provide informed consent.
- Less than 18 years of age.
- Standard colonoscopy exclusion criteria used at the GI lab at the University of Utah.
- Patients known or suspected to be pregnant.
- Patients with an ASA physical status of IV (A patient with severe systemic disease that is a constant threat to life) or V (A moribund patient who is not expected to survive without the operation).
- Patients known to have acute respiratory distress syndrome, severe COPD, or cardiovascular disease.
- If their oxygen saturation measured by pulse oximetry (SpO2) is below 93% while breathing room air prior to the procedure.
- Patients with severe medical condition(s) that in the view of the acting physician prohibits participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Utah South Jordan Health Center - Endoscopy
South Jordan, Utah, 84009
Kate Koniuch, MD, 801-213-4500, Kate.Koniuch@hsc.utah.edu
About this study
Official title: Evaluation of Oxygen Desaturation and Apnea Events With Supplemental Oxygen During Procedural Sedation in Colonoscopies
This study will compare apnea and oxygen desaturation events among various methods of supplemental oxygen delivery during procedural sedation in colonoscopy patients. The goals of the study are to track apnea (10 or more seconds without respiration) and oxygen desaturation (hemoglobin oxygen saturation less than 90%) events in colonoscopy patients receiving one of three different methods of supplemental oxygen administration. The first method is standard-of-care continuous flow oxygen therapy, where a constant flow of oxygen is administered through a nasal cannula or oxygen mask. The second method is synchronized flow oxygen therapy. This is a delivery method implemented in an FDA-cleared medical device (Sovant, Dynasthetics LLC) which delivers variable-volume oxygen pulses only as the patient inhales. The delivered oxygen pulses are commensurate to the set flow rate and the patient's respiratory rate. The third method is continuous positive airway pressure therapy (CPAP), where non-invasive pressure support is given to the patient's airway to help keep their airway open. The hypothesis being tested is that synchronized flow delivery and CPAP therapy will demonstrate reductions in apnea and oxygen desaturation events compared to traditional continuous flow oxygen therapy.
Read the detailed description
Sedation procedures such as colonoscopies involve administering drugs to patients that reduce awareness and pain without complete loss of consciousness. A side effect of these drugs is respiratory depression, where the patient's breathing becomes more shallow and less frequent. Another side effect is partial or complete obstruction of the airway by the airway tissue, inhibiting the flow of oxygen to the lungs. When a patient experiences significant respiratory depression or airway obstruction, they may not receive adequate oxygen, which may result in low hemoglobin oxygen saturation (SpO2), which is generally monitored with a probe on a finger. This may lead to inadequate oxygenation of tissues or organs and can lead to permanent organ damage or even death in severe cases.
The current standard approach to prevent oxygen desaturation during procedural sedation is supplemental oxygen therapy, usually administered through a nasal cannula or oxygen mask. The traditional method is continuous flow oxygen therapy, where a constant flow of oxygen is given. Research has demonstrated that while this does improve overall oxygen saturation levels during sedation, oxygen desaturation and apnea still frequently occur.
An FDA-cleared intelligent oxygen delivery device (Sovant, Dynasthetics LLC) that is relatively new to the market provides a new approach to supplemental oxygen delivery called synchronized flow, which delivers variable-volume pulses of high-flow oxygen only as the patient inhales. The volumes of the pulses are based on a set flow rate and the patients respiratory rate. Research has shown that higher oxygen concentrations reach the lungs when using synchronized flow delivery as opposed to continuous flow oxygen delivery, but research has yet to demonstrate that synchronized flow reduces oxygen desaturation events.
Research has demonstrated that continuous positive airway pressure (CPAP) therapy, which involves directing air flow into a tight-fitting mask over the patient's nostrils and/or mouth to stent open the airway, effectively reduces oxygen desaturation and apnea when administered with a non-invasive ventilator. However, non-invasive ventilators used for administering PAP therapy are expensive, large, require special training to operate, and often are not available in areas of the hospital where sedation procedures take place, making this a less-practical approach.
We have developed a smaller low-cost CPAP system for sedation as an additional software feature and disposable integrated into the FDA-cleared intelligent oxygen delivery device that also administers continuous flow and synchronized flow supplemental oxygen (Sovant, Dynasthetics LLC). The aim of the study is to administer supplemental oxygen to colonoscopy patients using these three different administration methods (continuous flow, synchronized flow, and CPAP therapy) and evaluate differences in oxygen desaturation (SpO2 < 90%) and apnea (10 seconds or more without respiration) events. We aim to evaluate the effectiveness of synchronized flow oxygen delivery compared to continuous flow oxygen delivery in reducing oxygen desaturation and apnea. We also aim to evaluate whether our compact and low-cost CPAP system can also effectively reduce oxygen desaturation and apnea compared to the current standard practice of continuous flow delivery.
- Being tested
- Breath-synchronized oxygen, CPAP, Control
- Keywords
- CPAP, apnea, desaturation, sedation, colonoscopy
- Medical subject headings
- Apnea, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath-synchronized oxygenDevice
Also called Synchronized Flow
This is breath-synchronized oxygen delivery of supplemental oxygen by the FDA-cleared Sovant device, where oxygen is given synchronously with the patient's inhalation only through a nasal cannula or non-rebreather oxygen mask.
CPAPDevice
Supplemental oxygen delivered via continuous positive airway pressure (CPAP) therapy through a tight-fitting mask over the patient's mouth and nose, where oxygen flow rate is automatically adjusted by the investigational devce to maintain the anesthetist-selected airway pressure.
ControlDevice
Also called Continuous flow
This is the traditional approach of administering oxygen at a constant flow rate chosen by the anesthetist through a nasal cannula or non-rebreather oxygen mask.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Oxygen Flow | Active comparator | This arm is the traditional supplemental oxygen delivery of providing a continuous oxygen flow through a nasal cannula or non-rebreather oxygen mask at a flow rate set by the anesthetist. Receives: Device: Control |
| Synchronized Oxygen Flow | Experimental | This arm is breath-synchronized oxygen delivery with the FDA-cleared Sovant oxygen delivery device through a nasal cannula or non-rebreather mask. Oxygen is pulsed at the beginning of the patient's inhalation and flow is discontinued the rest of the breath. Receives: Device: Breath-synchronized oxygen |
| CPAP | Experimental | This arm is oxygen delivery through continuous positive airway pressure (CPAP) therapy administered by an investigational device, where oxygen is given through a tight-fitting mask over the patient's mouth and nose. The oxygen flow rate is automatically adjusted by the device to maintain a set pressure in the patient's airway as selected by the anesthetist. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation AUC
The area under the hemoglobin oxygen saturation curve (AUC) will be calculated as the difference between the desaturation threshold of 90% and the recorded SpO2 integrated over the duration that SpO2 was below the 90% threshold.
Measured: The duration of the procedure
Secondary outcomes (1)
Apneic events
The number and duration of apneic events, with apnea defined as 10 seconds or more without respiration.
Measured: The duration of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start18 May 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oxygen DesaturationStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Model description
- Each patient will be randomly assigned one of three treatments to be used during their colonoscopy.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Kuck, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515755
- Sponsor's protocol ID
- IRB_00190788
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Evaluation of Oxygen Delivery Efficiency Using a Prototype Intelligent Oxygen Flowmeter. Kyle M. Burk, Sakata, et al STA 2017 Annual Mtg January 11-14, 2017, San Diego, California. Anesthesia & Analgesia 124(5S):p 1-137, May 2017
Fogarty M, Orr JA, Sakata D, Brewer L, Johnson K, Fang JC, Kuck K. A comparison of ventilation with a non-invasive ventilator versus standard O2 with a nasal cannula for colonoscopy with moderate sedation using propofol. J Clin Monit Comput. 2020 Dec;34(6):1215-1221. doi: 10.1007/s10877-019-00426-5. Epub 2019 Nov 23.
PubMed 31760586
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygen Desaturation and Apnea Events With Supplemental Oxygen During Procedural Sedation in Colonoscopies
- ClinicalTrials.gov ID
- NCT07515755
- Acronym / sponsor ID
- IRB_00190788
- Keywords
- CPAP, apnea, desaturation, sedation, colonoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare apnea and oxygen desaturation events among various methods of supplemental oxygen delivery during procedural sedation in colonoscopy patients. The goals of the study are to track apnea (10 or more seconds without respiration) and oxygen desaturation (hemoglobin oxygen saturation less than 90%) events in colonoscopy patients receiving one of three different methods of supplemental oxygen administration. The first method is standard-of-care continuous flow oxygen therapy, where a constant flow of oxygen is administered through a nasal cannula or oxygen mask. The second method is synchronized flow oxygen therapy. This is a delivery method implemented in an FDA-cleared medical device (Sovant, Dynasthetics LLC) which delivers variable-volume oxygen pulses only as the patient inhales. The delivered oxygen pulses are commensurate to the set flow rate and the patient's respiratory rate. The third method is continuous positive airway pressure therapy (CPAP), where non-invasive pressure support is given to the patient's airway to help keep their airway open. The hypothesis being tested is that synchronized flow delivery and CPAP therapy will demonstrate reductions in apnea and oxygen desaturation events compared to traditional continuous flow oxygen therapy.
Detailed description
Sedation procedures such as colonoscopies involve administering drugs to patients that reduce awareness and pain without complete loss of consciousness. A side effect of these drugs is respiratory depression, where the patient's breathing becomes more shallow and less frequent. Another side effect is partial or complete obstruction of the airway by the airway tissue, inhibiting the flow of oxygen to the lungs. When a patient experiences significant respiratory depression or airway obstruction, they may not receive adequate oxygen, which may result in low hemoglobin oxygen saturation (SpO2), which is generally monitored with a probe on a finger. This may lead to inadequate oxygenation of tissues or organs and can lead to permanent organ damage or even death in severe cases.
The current standard approach to prevent oxygen desaturation during procedural sedation is supplemental oxygen therapy, usually administered through a nasal cannula or oxygen mask. The traditional method is continuous flow oxygen therapy, where a constant flow of oxygen is given. Research has demonstrated that while this does improve overall oxygen saturation levels during sedation, oxygen desaturation and apnea still frequently occur.
An FDA-cleared intelligent oxygen delivery device (Sovant, Dynasthetics LLC) that is relatively new to the market provides a new approach to supplemental oxygen delivery called synchronized flow, which delivers variable-volume pulses of high-flow oxygen only as the patient inhales. The volumes of the pulses are based on a set flow rate and the patients respiratory rate. Research has shown that higher oxygen concentrations reach the lungs when using synchronized flow delivery as opposed to continuous flow oxygen delivery, but research has yet to demonstrate that synchronized flow reduces oxygen desaturation events.
Research has demonstrated that continuous positive airway pressure (CPAP) therapy, which involves directing air flow into a tight-fitting mask over the patient's nostrils and/or mouth to stent open the airway, effectively reduces oxygen desaturation and apnea when administered with a non-invasive ventilator. However, non-invasive ventilators used for administering PAP therapy are expensive, large, require special training to operate, and often are not available in areas of the hospital where sedation procedures take place, making this a less-practical approach.
We have developed a smaller low-cost CPAP system for sedation as an additional software feature and disposable integrated into the FDA-cleared intelligent oxygen delivery device that also administers continuous flow and synchronized flow supplemental oxygen (Sovant, Dynasthetics LLC). The aim of the study is to administer supplemental oxygen to colonoscopy patients using these three different administration methods (continuous flow, synchronized flow, and CPAP therapy) and evaluate differences in oxygen desaturation (SpO2 < 90%) and apnea (10 seconds or more without respiration) events. We aim to evaluate the effectiveness of synchronized flow oxygen delivery compared to continuous flow oxygen delivery in reducing oxygen desaturation and apnea. We also aim to evaluate whether our compact and low-cost CPAP system can also effectively reduce oxygen desaturation and apnea compared to the current standard practice of continuous flow delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each patient will be randomly assigned one of three treatments to be used during their colonoscopy.
| Arm | Type | Receives |
|---|---|---|
| Continuous Oxygen Flow | Active comparator | Device: ControlThis arm is the traditional supplemental oxygen delivery of providing a continuous oxygen flow through a nasal cannula or non-rebreather oxygen mask at a flow rate set by the anesthetist. |
| Synchronized Oxygen Flow | Experimental | Device: Breath-synchronized oxygenThis arm is breath-synchronized oxygen delivery with the FDA-cleared Sovant oxygen delivery device through a nasal cannula or non-rebreather mask. Oxygen is pulsed at the beginning of the patient's inhalation and flow is discontinued the rest of the breath. |
| CPAP | Experimental | Device: CPAPThis arm is oxygen delivery through continuous positive airway pressure (CPAP) therapy administered by an investigational device, where oxygen is given through a tight-fitting mask over the patient's mouth and nose. The oxygen flow rate is automatically adjusted by the device to maintain a set pressure in the patient's airway as selected by the anesthetist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient
- No life threatening conditions
- Undergoing colonoscopy procedures and receiving procedural sedation at the University of Utah Health clinic in South Jordan, Utah.
Key exclusion criteria (8 listed)
- Inability/refusal of subject to provide informed consent.
- Less than 18 years of age.
- Standard colonoscopy exclusion criteria used at the GI lab at the University of Utah.
- Patients known or suspected to be pregnant.
- Patients with an ASA physical status of IV (A patient with severe systemic disease that is a constant threat to life) or V (A moribund patient who is not expected to survive without the operation).
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 |
|---|---|---|
| Breath-synchronized oxygenAlso: Synchronized FlowThis is breath-synchronized oxygen delivery of supplemental oxygen by the FDA-cleared Sovant device, where oxygen is given synchronously with the patient's inhalation only through a nasal cannula or non-rebreather oxygen mask. | Device | Synchronized Oxygen Flow |
| CPAPSupplemental oxygen delivered via continuous positive airway pressure (CPAP) therapy through a tight-fitting mask over the patient's mouth and nose, where oxygen flow rate is automatically adjusted by the investigational devce to maintain the anesthetist-selected airway pressure. | Device | CPAP |
| ControlAlso: Continuous flowThis is the traditional approach of administering oxygen at a constant flow rate chosen by the anesthetist through a nasal cannula or non-rebreather oxygen mask. | Device | Continuous Oxygen Flow |
Primary outcome
Oxygen Saturation AUC
Time frame: The duration of the procedure
The area under the hemoglobin oxygen saturation curve (AUC) will be calculated as the difference between the desaturation threshold of 90% and the recorded SpO2 integrated over the duration that SpO2 was below the 90% threshold.
1 secondary outcome
Apneic events
Time frame: The duration of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- BackgroundEvaluation of Oxygen Delivery Efficiency Using a Prototype Intelligent Oxygen Flowmeter. Kyle M. Burk, Sakata, et al STA 2017 Annual Mtg January 11-14, 2017, San Diego, California. Anesthesia & Analgesia 124(5S):p 1-137, May 2017
- Background: PubMed 31760586Fogarty M, Orr JA, Sakata D, Brewer L, Johnson K, Fang JC, Kuck K. A comparison of ventilation with a non-invasive ventilator versus standard O2 with a nasal cannula for colonoscopy with moderate sedation using propofol. J Clin Monit Comput. 2020 Dec;34(6):1215-1221. doi: 10.1007/s10877-019-00426-5. Epub 2019 Nov 23.
- 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.
Kai Kuck, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath-synchronized oxygen and CPAP in people with Oxygen Desaturation and Apnea (Central and Obstructive), run by University of Utah 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 8 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: opening soon, as of the sponsor's last update on 7 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Kuck, PhD ((801) 581-6393, kai.kuck@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation AUC (time frame: The duration of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07515755, which also lists 2 linked publications.
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 7 Apr 2026.