Clinical trial NCT02757820: A Randomized Comparison of Pediatric I-gel, Air-Q With Classic Laryngeal Mask Airway
Official title: A Randomized Comparison of Pediatric I-gel, Air-Q With Classic Laryngeal Mask Airway in Terms of Clinical Performance and Fiber Optic Glottic View
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anesthesia
Keywords: anesthesia; airway; laryngeal mask airway; I-gel; Air-Q
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized trial will be to evaluate the clinical performance of the I-gel, air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery under general anesthesia.

Detailed description: The laryngeal mask airway (LMA) Classic has gained popularity for airway management in both anesthesia and resuscitation due to its ease of use. However, insertion of the LMA Classic is not always easy in children due to differences in airway anatomy compared with adults, and more complications are related to its use in younger children compared with adults.

The i-gel has been commercially available in sizes suitable for children since 2010. It has a non-inflatable cuff and an additional lumen for the active or passive drainage of gastric contents (except in size 1). It is available in four children's sizes (1, 1.5, 2 and 2.5).

The air-Q_ ILA, is easily inserted with the index finger of the right hand, while the anesthetist performed jaw's lift with left hand, without a rotational technique (Jagannathan N et al., 2011, Dar long et al, 2014 and Keil et al, 2015).

Oropharyngeal leak pressure is defined as the airway pressure at which air leaks into the mouth or enters the stomach (Hughes et al., 2012). This feature is the most common primary outcome parameter used to evaluate the safety and efficacy of supraglottic airway devices because high pressures generally indicate that adequate ventilation can be achieved without air leakage during positive pressure ventilation at high inspiratory pressures (Teoh et al., 2010).

Eligibility criteria: Inclusion Criteria:

Weight: 15-30 kg. Age: 2-9 years. Sex: both males and females. ASA physical status: 1-3. Operation: elective outpatient surgery in which airway management with a LMA would be appropriate.

Exclusion Criteria:

Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia, Potentially difficult airway. Patients with history of neck, respiratory, or digestive tract pathology. Patients with gastroesophageal reflux, gastrointestinal stenosis or stricture

Primary outcomes:
measure: Airway leak pressure
timeFrame: intraoperative
Secondary outcomes:
measure: Fiberoptic laryngoscopic view
timeFrame: intraoperative
measure: ventilation score
timeFrame: intraoperative
measure: Heart rate
timeFrame: intraoperative
measure: peripheral arterial oxygenation
timeFrame: intraoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university Pediatric hospital
state: Assiut Governorate
Study officials:
affiliation: Assistant professor, anesthesia department, faculty of medicine, Assiut university
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: