Anesthesia
Conditions
Keywords
Minimal Sedation nitrous oxide
Brief summary
To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of up to 72% nitrous oxide and ambient air.
Detailed description
This study assesses the Hand Held Nitrous Oxide Deliver Device which is intended to be used in nitrous oxide sedation systems by delivering a limited 16 grams of nitrous oxide over a total of 120 seconds of inhalation time. The device creates short term minimal sedation by delivering a maximum 72% USP grade nitrous oxide / 28 % ambient air combination which quickly drops to under 33% nitrous oxide / 67% ambient air in 60 seconds and stays steady until all the gas is expelled.
Interventions
OTHERThere are no other inteventions.
This device gives patients the opportunity to receive nitrous oxide where no such opportunity exists. There is no other intervention available that creates immediate short term minimal sedation.
Sponsors
Strata Medical Innovations
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient undergoing a painful office procedure or exam
Exclusion criteria
* Women that are Pregnant * Children under three years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide. | The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required. | This is a short acting device that delivers a small amount of nitrous oxide. The patient responds quickly and recovers quickly (approximately 6 minutes). |
Countries
United States
Contacts
Primary ContactMark W Aldana, B.S. MBA
Outcome results
None listed