Isolite and Dental Treatment Under Conscious Sedation

The University of Texas System (UT)

Status: Completed

Conditions: Dental Caries

Treatments: Device: Isolite System

Study type: Observational

Funder types: Other

Identifiers

NCT01683851

HSC200120233H

Details and patient eligibility

About

Hypothesis

The use of Isolite® system does not produce upper airway obstruction in the pediatric population during dental treatment with conscious sedation.

Purpose:

Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.

Objectives:

1. Determine changes in pulse rate
2. Determine changes in SpO2
3. Recognize breath sound's changes possibly associated with airway blockage
4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation
5. Relate the use of Isolite® with the frequency of head reposition to open the airway.

Full description

Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.

Enrollment: 20 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)
• 4-7 years of age
• Patients English and Spanish speaking

Exclusion criteria

• Upper airway infection
• Craniofacial anomalies