Hand Held Nitrous Oxide Delivery Device

Anesthesia Clinical Trial

— HHN  

Official title:

Safety and Efficacy of Hand Held Nitrous, a Device That Delivers 16 Grams of Nitrous Oxide Over 120 Seconds of Inhalation Time.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02119403
• Other study ID #: smi7531
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2014
• Last updated: April 17, 2014
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: Strata Medical Innovations
• Contact: Mark W Aldana, B.S. MBA
• Phone: 806-787-0756
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Any patient undergoing a painful office procedure or exam

Exclusion Criteria:

• Women that are Pregnant

• Children under three years of age

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• There 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.

Locations

Country	Name	City	State
United States	Lubbock Urology	Lubbock	Texas
United States	Other Medical Practices	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Strata Medical Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide.	This is a short acting device that delivers a small amount of nitrous oxide. The patient responds quickly and recovers quickly (approximately 6 minutes).	The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required.	Yes