Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-30 @ 1:22 PM
Study NCT ID:
NCT01683851
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2012-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolite and Dental Treatment Under Conscious Sedation
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: