Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2016-11-30
2026-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Only Arm
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
On Demand Oxygen Delivery
Supplemental oxygen flow is controlled such that it is on only during inhalation.
Traditional, Always-On, Oxygen Delivery
Supplemental oxygen flow is constantly on, irrespective of whether the patient is inhaling or exhaling.
Oxygen Flow Stopped
Supplemental oxygen flow is stopped completely for a brief period to allow undisturbed end-tidal oxygen and CO2 measurements
Interventions
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On Demand Oxygen Delivery
Supplemental oxygen flow is controlled such that it is on only during inhalation.
Traditional, Always-On, Oxygen Delivery
Supplemental oxygen flow is constantly on, irrespective of whether the patient is inhaling or exhaling.
Oxygen Flow Stopped
Supplemental oxygen flow is stopped completely for a brief period to allow undisturbed end-tidal oxygen and CO2 measurements
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Kai Kuck
Ph.D.
Principal Investigators
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Kai Kuck, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah Department of Anesthesiology
Locations
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University of Utah
Salt Lake City, Utah, United States
Countries
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References
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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.
Fuhrman 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.
Godbold 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.
Other Identifiers
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IRB_00094640
Identifier Type: -
Identifier Source: org_study_id
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