Demand-Driven Method for Gas Delivery in a Dental Setting

Summary

This study compares two methods of gas delivery in a dental setting: 1) demand-driven (DD) and 2) free-flow (FF).

Nitrous oxide and oxygen sedation (NOS) is a common form of minimal sedation for adult and paediatric patients undergoing dental procedures. In order for NOS devices to be utilized during dental treatment, dentists must be able to provide gas flow to the patient, and subsequently scavenge used and unused gasses. Gas delivery is via a nasal mask, since the oral cavity must be accessible to the dentist throughout treatment.

Current devices for NOS in the dental setting utilize a free-flow gas method, where nitrous oxide and oxygen are released continuously from their tanks. The flow rate is set by the dentist according to the patient's minute ventilation needs, and unused and exhaled gasses are scavenged via the nasal mask. The demand-driven gas flow method, where inspiration triggers gas flow, has been used successfully in other medical settings, such as in obstetrics, medical emergencies, and for patients with chronic obstructive pulmonary disease. However, in these settings the mask used covers both the nose and mouth, and patients can trigger the demand-driven method through inspiration of the nose or mouth. The demand-driven gas flow method has a significant gas-sparing advantage over the free-flow method. With a demand-driven method, the patient dictates the flow rate and gas is only delivered when they are inspiring, compared to the free-flow method which provide gas flow throughout inspiration and expiration. However, the demand-driven method have not been studied in a dental setting where flow can only be triggered through the nose. It is therefore unknown whether it is feasible or comfortable for patients to trigger a demand-driven method nasally when their mouth is open during dental treatment.

This study will aim to assess the feasibility and comfort of a nasal demand-driven gas delivery method utilizing 100% oxygen in healthy, adult participants in a simulated dental setting. If the device is feasible and comfortable with 100% oxygen in a simulated dental setting, future research can be conducted to assess its use for NOS for dental treatment.

Conditions

• Nitrous Oxide
• Dentistry
• Drug Delivery System
• Comfort
• Feasibility
• Drug Administration, Inhalation

Interventions

DEVICE

Demand-driven delivery method

The gas delivery device is set to the demand-driven setting. Patients must inspire through their nose to trigger the flow of gas.

DEVICE

Free-flow delivery method

The gas delivery device is set to a free-flow setting. Gas flows through the system at a rate determined by the operator. Standard flow rate is 6 liters per minute. Patients do not need to inspire through their nose to trigger the flow of gas.

Sponsors & Collaborators

• O-Two Medical Technologies

  collaborator UNKNOWN

• University of Toronto

  lead OTHER

Principal Investigators

• Carilynne Yarascavitch, BSc DDS MSc · University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-31

Primary Completion

2020-10-31

Completion

2020-10-31

Countries

• Canada

Study Locations