General Anesthesia Clinical Trial
Verified date | September 2014 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 108 Months |
Eligibility |
Inclusion Criteria: - Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway Exclusion Criteria: - Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ease of insertion (insertion parameter) | Ease of insertion was graded from 1 to 4 | During and 1 min after insertion of each device | No |
Primary | airway leak pressure | within 5 min after insertion of each device | No | |
Secondary | Insertion time (insertion parameter) | insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography. | During and 1 min after insertion of each device | No |
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