On-Demand Oxygen Delivery System Study

Patient Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02962570
• Other study ID #: IRB_00094640
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Oxygen Delivery
• Patient Monitoring

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

Outcome

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