On-Demand Oxygen Delivery System Study

Not Applicable

Active, not recruiting

Interventions: Device: On Demand Oxygen Delivery
Device: Traditional, Always-On, Oxygen Delivery
Device: Oxygen Flow Stopped

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Only Arm	On Demand Oxygen Delivery	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
Only Arm	Traditional, Always-On, Oxygen Delivery	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
Only Arm	Oxygen Flow Stopped	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

Primary Outcome Measures

Name	Time	Method
End-tidal Oxygen	measured every 140 seconds minutes throughout the surgical procedure	Did the novel system increase end-tidal oxygen?
Oxygen Saturation	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	measured every 140 seconds minutes throughout the surgical procedure	Was end-tidal carbon dioxide measured more accurately using the novel system?

Secondary Outcome Measures

Name	Time	Method

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