Clinical trial NCT01683851: Isolite and Dental Treatment Under Conscious Sedation
Official title: Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: pediatric
conscious sedation
mouthpiece
airway
isolite system
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients in need of a sedation dental appointment

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Isolite and Dental Treatment Under Conscious Sedation
timeFrame: 120 minutes (sedation appointment time)
Secondary outcomes:
measure: Isolite and Dental Treatment Under Conscious Sedation
timeFrame: 120 minutes (sedation appointment)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center-Dental School
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center-Ricardo Salinas Dental Clinic
state: Texas
Study officials:
affiliation: University of Texas
name: Claudia I Contreras, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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