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

NCT02757820 | Completed Phase 2 DMC

• 1 other identifier: IRB00008718/ref. 89
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

anesthesia; airway; laryngeal mask airway; I-gel; Air-Q

Outcome Measures

Primary Outcomes (1)

• Airway leak pressure

  Airway leak pressure will be determined by closing the adjustable expiratory pressure-limiting (APL) valve and setting the fresh gas flow rate to 3 L/min. The airway pressure at which an audible leak in the mouth is heard is recorded as the "leak pressure". If leak pressure reached 35 cmH2O, the expiratory valve will be opened. After adjusting the APL valve to 35 cmH2O, the maximum tidal volume (TVmax) will be measured by squeezing the balloon of anesthesia circuit until an audible leak occurred. Airway pressures were not allowed to exceed 35 cmH2O.

  intraoperative

Secondary Outcomes (4)

• Fiberoptic laryngoscopic view

  intraoperative

• ventilation score

  intraoperative

• Heart rate

  intraoperative

• peripheral arterial oxygenation

  intraoperative

Study Arms (3)

LMA classic

ACTIVE COMPARATOR

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.

Device: LMA Classic

I-gel

ACTIVE COMPARATOR

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.

Device: i- gel

Air-Q

ACTIVE COMPARATOR

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.

Device: Air-Q

Interventions

LMA Classic 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.

LMA classic

i- gel 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.

I-gel

Air-Q 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.

Air-Q

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

Location

Study Officials

• Hala S Abdel-Ghaffar, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 2, 2016
• Study Start: June 14, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

EG (1)