Hand Held Nitrous Oxide Delivery Device (HHN)

Strata Medical Innovations

Status: Unknown

Conditions: Anesthesia

Treatments: Other: There are no other inteventions.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02119403

smi7531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient undergoing a painful office procedure or exam

Exclusion criteria

• Women that are Pregnant
• Children under three years of age

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Hand Held NitrousTM

Experimental group

Description:

There are no other interventions to this device

Treatment:

Other: There are no other inteventions.