Clinical Trials Logo
  1. Home
  2. General Anesthesia
  3. NCT01738854
  4. Details
NCT01738854 Clinical Trial

The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01738854
Other study ID # 1-2012-0043
Secondary ID
Status Completed
Phase N/A
First received November 22, 2012
Last updated April 6, 2014
Start date November 2012
Est. completion date July 2013

Study information
Verified date April 2014
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at various intracuff pressure in children.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date July 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 9 Years
Eligibility Inclusion Criteria:

- Pediatric patients (less than 108months of age)

- scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5

Exclusion Criteria:

- Patients with an abnormal airway,

- reactive airway disease,

- gastroesophageal reflux disease,

- chronic respiratory disease,

- a history of an upper respiratory tract infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

Intervention

Procedure:
• intracuff pressure by cuff pressure manometer
36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.

Locations
Country Name City State
Korea, Republic of Severance hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Zhang L, Seet E, Mehta V, Subramanyam R, Ankichetty SP, Wong DT, Chung F. Oropharyngeal leak pressure with the laryngeal mask airway Supreme™ at different intracuff pressures: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):624-9. doi: 10.1007/s12630-011-9514-6. Epub 2011 Apr 30. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The oropharyngeal leak pressure volume approximately 5 minutes after adjusting intracuff pressure No
See also
  Status Clinical Trial Phase
Completed NCT04577430 - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period N/A
Completed NCT03708692 - Menstrual Cycle Phases on Recovery and Cognitive Function
Recruiting NCT03422315 - Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection N/A
Completed NCT02771067 - The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position N/A
Completed NCT05063461 - Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane N/A
Completed NCT03294226 - Comparison of AuraGain With I-gel for Pediatric Patients N/A
Not yet recruiting NCT03643029 - The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy N/A
Completed NCT01945411 - Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway N/A
Completed NCT01705743 - Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG Phase 4
Not yet recruiting NCT01678066 - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor N/A
Completed NCT00972491 - The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia N/A
Completed NCT01096212 - Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia Phase 4
Completed NCT00741507 - Unhealthy Alcohol Drinking and Anesthetic Requirement in Women N/A
Completed NCT00532402 - Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas N/A
Completed NCT00599066 - Intraoperative M-Entropy Measurements N/A
Completed NCT00468494 - Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia? N/A
Recruiting NCT00492453 - Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy N/A
Recruiting NCT03745079 - Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
Completed NCT04094376 - Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia N/A
Enrolling by invitation NCT03672734 - Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia