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Clinical Trials/NCT02962570
NCT02962570
Active, not recruiting
Not Applicable

Comparison of an On-Demand Oxygen Delivery System to Continuous Flow Supplemental Oxygen in the Operating/Procedure Room

University of Utah1 site in 1 country100 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oxygen Delivery
Sponsor
University of Utah
Enrollment
100
Locations
1
Primary Endpoint
End-tidal Oxygen
Status
Active, not recruiting
Last Updated
last year

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
November 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kai Kuck

Ph.D.

University of Utah

Eligibility Criteria

Inclusion Criteria

  • ASA class I-III

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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?

Study Sites (1)

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