Clinical trial NCT02962570: On-Demand Oxygen Delivery System Study
Official title: Comparison of an On-Demand Oxygen Delivery System to Continuous Flow Supplemental Oxygen in the Operating/Procedure Room
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Oxygen Delivery
Patient Monitoring
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: End-tidal Oxygen
timeFrame: measured every 140 seconds minutes throughout the surgical procedure
measure: Oxygen Saturation
timeFrame: measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure
measure: End-tidal Carbon Dioxide
timeFrame: measured every 140 seconds minutes throughout the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah Department of Anesthesiology
name: Kai Kuck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.