Status:
COMPLETED
A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Intraoperative Ventilation
Eligibility:
All Genders
12-5 years
Phase:
NA
Brief Summary
The purpose of this research study is to compare difference between breathing by oneself or with the partial help from an anesthesia machine in children under general anesthesia.
Detailed Description
The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and allows the patient to breathe in and out adequately under general anesthesia (GA). The ProSeal™ LMA (PLMA™) is...
Eligibility Criteria
Inclusion
- ASA physical classification 1,2 (Healthy or relatively healthy children)
- Subjects scheduled for outpatient surgical procedures.
- Surgical procedure anticipated to be \< 90 minutes
- Subject weight of ≤ 20 kg (44 lbs)
- Subject age of 12 months to 5 years (inclusive)
Exclusion
- Inpatient
- ASA physical classification of 3, 4 or E (sick children)
- Risk of aspiration
- Subjects with malignant hyperthermia or family history of malignant hyperthermia
- Subjects with tracheostomies
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00966433
Start Date
August 1 2009
End Date
October 1 2009
Last Update
December 5 2018
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157