Status:
COMPLETED
A Comparison of Different Ventilation Strategies in Infants Using the PLMA™
Lead Sponsor:
Wake Forest University
Conditions:
Ventilation
Eligibility:
All Genders
1-11 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 infants under general anesthesia. Hypothesis: Infants u...
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™ laryngeal mask...
Eligibility Criteria
Inclusion
- ASA (American Society of Anesthesiologists) physical classification of 1 or 2
- Outpatient surgical procedures
- Surgical procedure anticipated to be \< 90 minutes
- Subject age of 1 - 11 months (inclusive)
Exclusion
- Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation
- ASA physical classification of 3, 4 or E
- Premature infants or infants \< 44 weeks post-conceptual age
- Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia.
- Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated.
- Patients with tracheostomies- The individual's airway is already established and PLMA™ placement is not required.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03235817
Start Date
December 1 2009
End Date
July 1 2010
Last Update
March 18 2022
Active Locations (1)
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1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157