I-gel Versus Air-Q LMA for Pediatric Patients

I-gel Versus Air-Q LMA for Pediatric Patients Undergoing Short-duration Surgical Procedures

This study targets to compare insertion facility, effect on hemodynamic parameters and effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing short-duration surgical procedures.

Study Overview

• Status: Completed
• Conditions: Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA
• Intervention / Treatment: Other: LMA i gel

Detailed Description

The patient were divided into 2 groups. I gel group and Air Q group according to LMA type used to maintain airway ventilation.

The patients were compared according to insertion facility, effect on hemodynamic parameters and effective ventilation.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA grade I-II
• operative time of ≤60 minutes

Exclusion Criteria:

• age >10 years
• ASA grade ≥II
• current or recently resolved upper respiratory tract infection
• presence of oropharynx or laryngeal pathologies or congenital anomalies
• pathologies inducing reflux or increasing the possibility of aspiration
• allergy to anaesthetic or drugs to be used, renal, cardiac or hepatic diseases, or bronchial asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: i gel; I gel LMA was inserted for all patients	Other: LMA i gel; insertion of LMA for maintaining airway during anesthesia; Other Names: LMA Air Q
Active Comparator: Air Q LMA; Air Q LMA was inserted for all patients	Other: LMA i gel; insertion of LMA for maintaining airway during anesthesia; Other Names: LMA Air Q

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supraglottic device success rate	Fitness of LMA for ventilation	60 minutes

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ASUH1421/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No