Oxygen DeliveryNCT02962570
On-Demand Oxygen Delivery System Study
A study testing On Demand Oxygen Delivery, Traditional, Always-On, Oxygen Delivery and Oxygen Flow Stopped in people with Oxygen Delivery and Patient Monitoring, run by University of Utah at 1 site in United States.
Trial summary
The main goal of this study is to determine if supplemental oxygen given only when the patient is inspiring (demand delivery) is more effective than constant-flow oxygen given during all phases of the breath regardless if the patient is breathing it in. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Delivery, Patient Monitoring
- What is being tested?
- On Demand Oxygen Delivery, Traditional, Always-On, Oxygen Delivery and Oxygen Flow Stopped
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 1 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-III
Who cannot join
- Procedures scheduled for a lime less than 20 minutes
- Age < 18 years
- Baseline SpO2 (arterial oxygen saturation as measured by pulse oximetry) < 93% on room air
- ARDS (Acute respiratory distress syndrome), lung disease, cardiovascular disease
- ASA class IV or above
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of an On-Demand Oxygen Delivery System to Continuous Flow Supplemental Oxygen in the Operating/Procedure Room
The main goal of this study is to determine if supplemental oxygen given only when the patient is inspiring (demand delivery) is more effective than constant-flow oxygen given during all phases of the breath regardless if the patient is breathing it in. A previous study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given in demand (inhalation only) mode. A secondary goal is to determine in patients, whether turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon Dioxide) monitoring. This was found to be the case in the previous volunteer study.
The investigators want to determine if these improvements are also observable in relatively healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand mode will be determined by measuring the resulting difference in oxygen saturation and end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2 measurement will be compared with those during the brief time when O2 flow is stopped.
- Conditions
- Oxygen Delivery, Patient Monitoring
- Being tested
- On Demand Oxygen Delivery, Traditional, Always-On, Oxygen Delivery, Oxygen Flow Stopped
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On Demand Oxygen DeliveryDevice
Supplemental oxygen flow is controlled such that it is on only during inhalation.
Traditional, Always-On, Oxygen DeliveryDevice
Supplemental oxygen flow is constantly on, irrespective of whether the patient is inhaling or exhaling.
Oxygen Flow StoppedDevice
Supplemental oxygen flow is stopped completely for a brief period to allow undisturbed end-tidal oxygen and CO2 measurements
| Study group | Role | What they receive |
|---|---|---|
| Only Arm | Experimental | Two minutes: Intervention: Device: On Demand Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped
Two minutes intervention: Device: Traditional, Always-On, Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped
Repeat until the end of the surgical procedure Receives: Device: On Demand Oxygen Delivery; Device: Traditional, Always-On, Oxygen Delivery; Device: Oxygen Flow Stopped |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal Oxygen
Did the novel system increase end-tidal oxygen?
Measured: measured every 140 seconds minutes throughout the surgical procedure
Oxygen Saturation
Did the novel system increase oxygen saturation?
Measured: measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure
End-tidal Carbon Dioxide
Was end-tidal carbon dioxide measured more accurately using the novel system?
Measured: measured every 140 seconds minutes throughout the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oxygen DeliveryStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Kuck, University of Utah
- Investigators
- Kai Kuck, Ph.D., Principal investigator, University of Utah Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962570
- Sponsor's protocol ID
- IRB_00094640
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2016
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
Bliss PL, McCoy RW, Adams AB. Characteristics of demand oxygen delivery systems: maximum output and setting recommendations. Respir Care. 2004 Feb;49(2):160-5.
PubMed 14744265Fuhrman C, Chouaid C, Herigault R, Housset B, Adnot S. Comparison of four demand oxygen delivery systems at rest and during exercise for chronic obstructive pulmonary disease. Respir Med. 2004 Oct;98(10):938-44. doi: 10.1016/j.rmed.2004.03.010.
PubMed 15481269Godbold S, Lowe G, Willis R. Healthcare Professionals Accuracy and Consistency in Setting Oxygen Flowmeters for Patients in an Intensive Care Unit. Respir. Care 59(10):OF26, December 2014.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an On-Demand Oxygen Delivery System to Continuous Flow Supplemental Oxygen in the Operating/Procedure Room
- ClinicalTrials.gov ID
- NCT02962570
- Acronym / sponsor ID
- IRB_00094640
- Conditions
- Oxygen Delivery, Patient Monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- 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.
The main goal of this study is to determine if supplemental oxygen given only when the patient is inspiring (demand delivery) is more effective than constant-flow oxygen given during all phases of the breath regardless if the patient is breathing it in. A previous study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given in demand (inhalation only) mode. A secondary goal is to determine in patients, whether turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon Dioxide) monitoring. This was found to be the case in the previous volunteer study.
The investigators want to determine if these improvements are also observable in relatively healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand mode will be determined by measuring the resulting difference in oxygen saturation and end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2 measurement will be compared with those during the brief time when O2 flow is stopped.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only Arm | Experimental | Device: On Demand Oxygen Delivery, Device: Traditional, Always-On, Oxygen Delivery, Device: Oxygen Flow StoppedTwo minutes: Intervention: Device: On Demand Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped Two minutes intervention: Device: Traditional, Always-On, Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped Repeat until the end of the surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA class I-III
Key exclusion criteria (6 listed)
- Procedures scheduled for a lime less than 20 minutes
- Age < 18 years
- Baseline SpO2 (arterial oxygen saturation as measured by pulse oximetry) < 93% on room air
- ARDS (Acute respiratory distress syndrome), lung disease, cardiovascular disease
- ASA class IV or above
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 |
|---|---|---|
| On Demand Oxygen DeliverySupplemental oxygen flow is controlled such that it is on only during inhalation. | Device | Only Arm |
| Traditional, Always-On, Oxygen DeliverySupplemental oxygen flow is constantly on, irrespective of whether the patient is inhaling or exhaling. | Device | Only Arm |
| Oxygen Flow StoppedSupplemental oxygen flow is stopped completely for a brief period to allow undisturbed end-tidal oxygen and CO2 measurements | Device | Only Arm |
Primary outcome
End-tidal Oxygen
Time frame: measured every 140 seconds minutes throughout the surgical procedure
Did the novel system increase end-tidal oxygen?
Oxygen Saturation
Time frame: measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure
Did the novel system increase oxygen saturation?
End-tidal Carbon Dioxide
Time frame: measured every 140 seconds minutes throughout the surgical procedure
Was end-tidal carbon dioxide measured more accurately using the novel system?
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 30 Apr 2026.
- Background: PubMed 14744265Bliss PL, McCoy RW, Adams AB. Characteristics of demand oxygen delivery systems: maximum output and setting recommendations. Respir Care. 2004 Feb;49(2):160-5.
- Background: PubMed 15481269Fuhrman C, Chouaid C, Herigault R, Housset B, Adnot S. Comparison of four demand oxygen delivery systems at rest and during exercise for chronic obstructive pulmonary disease. Respir Med. 2004 Oct;98(10):938-44. doi: 10.1016/j.rmed.2004.03.010.
- BackgroundGodbold S, Lowe G, Willis R. Healthcare Professionals Accuracy and Consistency in Setting Oxygen Flowmeters for Patients in an Intensive Care Unit. Respir. Care 59(10):OF26, December 2014.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
Related trials for Oxygen Delivery
Not yet recruitingObservational study
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Cardiac Surgery
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Effect of Automated Oxygen Control on Early-childhood Lung Mechanics
Prematurity, Respiratory Distress Neonatal
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Elevated Midline Positioning During Diaper Change in Preterm Infants
Infant, Premature, Diseases, Premature Birth of Newborn
RecruitingObservational study
POASAC Study (Preoperative Anemia Severity and Classification Study)
Anemia
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
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.
Kai Kuck, Ph.D. principal investigator
University of Utah Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On Demand Oxygen Delivery, Traditional, Always-On, Oxygen Delivery and Oxygen Flow Stopped in people with Oxygen Delivery and Patient Monitoring, 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 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?
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?
End-tidal Oxygen (time frame: measured every 140 seconds minutes throughout the surgical procedure). The study lists 3 primary outcomes in all. 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 NCT02962570, which also lists 3 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 30 Apr 2026.