I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laryngeal Masks
- Sponsor
- King Saud University
- Enrollment
- 112
- Primary Endpoint
- Airway Leak Pressure
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis.
This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.
Detailed Description
Laryngeal mask airways (LMAs) are in practice of anesthesia since early 1980s. Pediatric and neonatal patients (including ex-premature) have also been benefited by the use of LMA. There are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat, post operative hoarseness and coughing at the time of extubation, greater hemodynamic and intraocular pressure (IOP) stability. LMA has been recognized internationally in control of airway in difficult and failed intubation. There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other (silicone, polyvinyl chloride or soft gel). There have been several randomized controlled studies comparing different LMAs in adults, however, the literature is sparse in which such comparison has been made in patients with weight 10 kg or below.
Investigators
Dr Abdulrahman Alzahem
Associate Professor and Consultant
King Saud University
Eligibility Criteria
Inclusion Criteria
- •Elective surgical procedures
- •No muscle relaxant agents
- •No other comorbidities
Exclusion Criteria
- •Emergency surgical procedures
- •Full stomach
- •Subjects with upper respiratory tract infection
- •Failed caudal block
Outcomes
Primary Outcomes
Airway Leak Pressure
Time Frame: 17 months
It will be measured in mmHg unit and the expiratory valve will be closed with a fresh gas flow of 3 l.min-1 until an audible leak is heard, airway pressure will not be allowed to exceed 25 cmH2O), and then released completely
Secondary Outcomes
- Success at first attempt(18 months)
- Oxygen Desaturation less than 90%(18 months)
- Gastric Insufflation(18 months)
- Manipulation of the Device(18 months)
- Effective airway time(18 months)
- Ease of insertion(18 months)