Patient Monitoring Clinical Trial
Official title:
Comparison of an On-Demand Oxygen Delivery System to Continuous Flow Supplemental Oxygen in the Operating/Procedure Room
Verified date | November 2023 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | November 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
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. — View 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. — View 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | End-tidal Oxygen | Did the novel system increase end-tidal oxygen? | measured every 140 seconds minutes throughout the surgical procedure | |
Primary | Oxygen Saturation | Did the novel system increase oxygen saturation? | measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure | |
Primary | End-tidal Carbon Dioxide | Was end-tidal carbon dioxide measured more accurately using the novel system? | measured every 140 seconds minutes throughout the surgical procedure |
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