A Randomized Comparison of Pediatric I-gel, Air-Q With Classic Laryngeal Mask Airway

NCT ID: NCT02757820

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-14
• Study Completion Date: 2018-04-30

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).

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LMA classic

Patients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air.

Group Type: ACTIVE_COMPARATOR

LMA Classic

Intervention Type: DEVICE

Patients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air.

I-gel

Patients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.

Group Type: ACTIVE_COMPARATOR

i- gel

Intervention Type: DEVICE

Patients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.

Air-Q

Patients will be anesthetized using Air-Q\_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.

Group Type: ACTIVE_COMPARATOR

Air-Q

Intervention Type: DEVICE

Patients will be anesthetized using Air-Q\_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.

Interventions

LMA Classic

Patients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air.

Intervention Type: DEVICE

i- gel

Patients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.

Intervention Type: DEVICE

Air-Q

Patients will be anesthetized using Air-Q\_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor, anesthesia department, faculty of medicine, Assiut university

Locations

Assiut university Pediatric hospital

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB00008718/ref. 89

Identifier Type: -

Identifier Source: org_study_id