MedTrace Logo

Comparison Between Three Supraglottic Airway Devices ProSeal Laryngeal Mask Airway, Air-Q LMA and Ambu AuraGain

NCT04045899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-08-06

No results posted yet for this study

Summary

The present study entitled, "A Randomized Controlled Study Comparing ProSeal Laryngeal Mask Airway, Air-Q LMA and Ambu AuraGain in mechanically ventilated patients." was conducted in during the period Nov 2016 - Aug 2018.

The Aim of the study was to compare the clinical performance of ProSeal-LMA (P-LMA) ,Air-Q and Ambu AuraGain in terms of efficacy and safety in anaesthetized and paralyzed patients on mechanical ventilation undergoing elective surgical procedures.

Objective was to study the three supraglottic devices with respect to following parameters:-number of insertion attempts and overall success rate, ease of insertion of device, time taken for placement of device, airway sealing pressure, glottic view, number of attempts of gastric tube placement, hemodynamic parameters: heart rate and mean arterial pressure: pre-insertion and 0,1,3,5 and 10 minutes post insertion and complications noted if any: blood staining of device and tongue, lip and dental trauma, laryngospasm ,sore throat, dysphagia, hoarseness of voice.

It was a randomized prospective single blind comparative study comprised of 150 ASA I - II patients, aged 18-65 years of either sex who weighed between 40 to 60 kg scheduled for elective surgical procedure of duration not more than 90 mins. After a thorough pre-anaesthetic check-up, informed written consent was obtained and the patients were randomized into 3 groups of 50 patients each as Group P(Proseal), Group Q (Air Q) and Group A (AuraGain) by computer generated randomization sequence.

Conditions

  • Proseal LMA vs Air-Q LMA vs Ambu AurGain LMA

Interventions

DEVICE

Proseal LMA

The Proseal Laryngeal Mask Airway (p-LMA) has a dual cuff modified to provide better sealing, and a drainage tube for gastric tube insertion. These features attribute in increasing the safety of the p-LMA when used with positive pressure ventilation.

DEVICE

Air-Q LMA

Air-Q LMA has a self-pressurizing cuff which inflates to adequate pressure during positive pressure ventilation thus eliminating the adverse effects of cuff over inflation associated with the use of Supraglottic airway device with an inflatable cuff.

DEVICE

Ambu AuraGain LMA

The AmbuAuraGain™ is a disposable, preformed second generation SAD, anatomically curved with integrated gastric access and intubation capability, taking patient safety and airway management efficiency to a new level.

Sponsors & Collaborators

  • Dr.Mahak Mehta

    lead OTHER

Principal Investigators

  • MAHAK MEHTA, MD · M.B.B.S M.D Anaesthesia GMC Haldwani(Nainital)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-08-31
Completion
2018-08-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045899 on ClinicalTrials.gov