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

August 2, 2019 updated by: Dr.Mahak Mehta

"A Randomized Controlled Study Comparing ProSeal Laryngeal Mask Airway, Air-Q LMA and Ambu AuraGain in Mechanically Ventilated Patients"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study PLMA, Air-Q® and Ambu AuraGain were compared undergoing elective surgeries under general anaesthesia. Primary outcome measure was insertion time. Airway sealing pressure,ease of insertion, number of attempts,overall success rate, glottis view,number of attempts of gastric tube placement , hemodynamic parameters and complications were also compared.

After approval from the institutional ethical committee, 150 patients were studied in a randomised prospective study, designed to compare PLMA , Air-Q® and Ambu AuraGain .The period of the study was from nov 2016 to aug 2018. This study was conducted according to Good Clinical Practice standards and the Helsinki Declaration.

The American Society of Anesthesiologists (ASA) physical status I and II patients, between 18-65 years of age, weighing from 40 to 60 kg of either sex, undergoing elective surgical procedures of duration not more than 90 minutes were selected for the study. The exclusion criteria included patients with anticipated difficult airway (mouth opening of <2 finger, Mallampati Score 4, limited neck extension, history of previous difficult intubation), upper respiratory tract infections,airway related conditions such as trismus, trauma or mass, cervical spine disease, obese with body mass index (BMI) ≥25kg/m2 ,pregnant females, patients at risk of aspiration (full stomach, hiatus hernia, gastro-oesophageal reflux disease, emergency surgery)and laparoscopic surgeries. Neck movement was assessed as Class: I-No reduction in movement, II-1/3rd reduction, III-2/3rd reduction, IV-Complete reduction.

Following detailed pre-anaesthetic check-up, informed written consent was obtained from all patients fulfilling the required criteria.Patients were randomly allocated into three groups namely Group P(ProSeal,n=50) ,Group Q (Air-Q®, n = 50) and Group A (AuraGain™, n = 50) using computer-generated randomisation sequence. Participants were assigned to specific groups by the operating room nurse in charge.

After attaching the standard monitors(ASA recommended), patients were pre-medicated with injection midazolam 0.05 mg/kg, glycopyrrolate 0.2 mg, dexamethasone 4 mg and nalbuphine 0.02mg/kg intravenously. All patients were pre-oxygenated for 3 min, and anaesthesia was induced with injection propofol 2 mg/kg. Injection vecuronium 0.1 mg/kg was given for neuromuscular blockade.

PLMA or Air-Q® or AuraGain™ appropriate for weight or/and height was inserted as per the manufacturers guidelines.After successful insertion, the cuff was inflated with air according to the size and type of LMA as per manufacturers guidelines, to prevent audible and palpable air leak. An effective airway was confirmed by bilateral symmetrical chest expansion on manual ventilation, auscultation of breath sounds, square waveform on capnography. Devices were fixed with adhesive tape applied to the maxilla on one side of the patient's face and passed over and under the tube in a single loop before fixing to the opposite maxilla.

Anaesthesia was maintained with oxygen, nitrous oxide and isoflurane and intermittent positive pressure ventilation. Haemodynamic parameters[heart rate(HR), mean arterial pressure(MAP)]were monitored before and after the insertion of the device. A lubricated gastric tube was placed in the stomach through the gastric channel. At the end of surgical procedure, anaesthesia was discontinued and residual neuromuscular blockade reversed with injection neostigmine and glycopyrrolate, followed by device removal. Complication if any was noted.

Insertion time, number of insertion attempts, overall success rate, ease of insertion, airway sealing pressure, glottis view, number of attempts of gastric tube insertion, hemodynamic parameters (HR and MAP) preinduction, induction and 1,3,5 and 10mins post induction and complications were noted. One attempt was defined as insertion of the LMA between the teeth until the LMA will be deemed to be correctly placed and its cuff will be properly inflated. In case of insertion attempts, maximum of three attempts were allowed. An attempt was considered unsuccessful, if there was failure to negotiate the device beyond oropharynx, significant leak present (both audible and auscultatory) or inadequate ventilation with EtCO2>45 mmHg. Failure of a device was defined as three unsuccessful insertion attempts or inadequate ventilation. After failure of three attempts, intubation was performed using conventional rigid laryngoscopy and case was recorded as failed and also deleted from the study. The ease of insertion of device based on Visual Analogue Scale(VAS) was recorded.0 was considered the easiest insertion of device and 10 being the most difficult insertion.Insertion time was defined as time interval (in seconds) elapsed from insertion of LMA between the dental arches until the confirmation of successful ventilation determined by chest wall movement, auscultation of breath sounds and square wave capnographic curves and no oropharyngeal leak with peak airway pressure ≥ 20cmH2O, which was recorded by an independent observer.The airway sealing pressure was measured by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min and recording the airway pressure at which equilibrium is reached. At this stage, a leak at mouth and stomach was ascertained. Glottic viewing was assessed by insertion of the fibreoptic bronchoscope through the airway channel of the respective LMA.A maximum of two attempts were allowed for gastric tube placement. Its correct placement was confirmed by injection of air and epigastric auscultation or aspiration of gastric contents. Failure was defined as inability to advance the orogastric tube into the stomach within two attempts. Blood staining of the device and tongue, lip or dental trauma was noted. Incidence of laryngospasm or hypoxia (defined as oxygen saturation <92%), if any, in intra-operative period was noted and managed accordingly. In post-operative period, an investigator blinded to study asked the patients about the signs of sore throat, dysphagia and hoarseness of voice. Incidence of hoarseness and sore throat, whether present or absent, were enquired in 24 h post-operatively.

The primary outcome measure of the study was insertion time. Based on a previous study investigators found mean insertion time in PLMA group was 23.43 seconds and SD of 3.54. Based on that, taking alpha 0.05, β =0.90 and 25% difference between the means as significant, investigators calculated 47 patients were required in each group; hence, the sample size was increased to 50 patients each.

The data were recorded in a Microsoft Excel Spreadsheet and analysed using SPSS statistics software version 24 (IBM SPSS Inc., Chicago, IL, USA). Continuous numerical variables were presented as mean (standard deviation) and intergroup differences were compared using one-way analysis of variance with post hoc correction. Categorical variables were presented as ratio or as n (%) and inter-group differences were compared using Kruskall-Wallis test. The P< 0.05 was considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: • American Society of Anaesthesiologists (ASA) class I/II.

  • Age 18-65 years of either sex.
  • Weight between 40-60 kg of either sex.
  • Elective Surgical procedures of duration not more than 90 minutes with no need for endotracheal intubation.

Exclusion Criteria:

  • • Patients with anticipated difficult airway(Mouth opening of <2 finger, Mallampati class 4,limited neck extension, history of previous difficult intubation).

    • Restricted mouth opening
    • Pregnant females
    • Cervical spine disease
    • Obese with body mass index ≥25kg/m2.
    • Patients with upper respiratory tract infections.
    • Patients at the risk of gastroesophageal regurgitation (eg hiatus hernia,sepsis, Diabetes Mellitus,obesity,pregnancy or a history of upper gastrointestinal surgery)
    • Laparoscopic surgeries
    • Patients with airway related conditions such as trismus,trauma or mass.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ProSeal Laryngeal Mask Airway Group
ProSeal LMA was inserted in 50 patients
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.
Experimental: Air-Q LMA Group
Air-Q LMA was inserted in 50 patients
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.
Experimental: Ambu AuraGain LMA Group
Ambu AuraGain was inserted in 50 patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion Time of device measured in seconds
Time Frame: 10 minutes

Time of insertion:

The time interval(seconds) elapsed from insertion of SAD between the dental arches until the confirmation of successful ventilation determined by chest wall movement,auscultation of breath sounds and square wave capnographic curves and no oropharyngeal leak with peak airway pressure >/= 20 cm of H2O.The time will be measured with the help of stop watch.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts of insertion of device
Time Frame: 15 minutes

Attempt will be defined as insertion of the LMA between the teeth until the LMA will be deemed to be correctly placed and its cuff will be properly inflated.

A maximum of three attempts will be allowed. An attempt will be considered unsuccessful if -

  • Failure to negotiate beyond oropharynx.
  • Significant Leak present (both audible and auscultatory)
  • Inadequate ventilation to be confirmed by Et-CO2 >45 mmHg. Failure of a device is identified as three unsuccessful insertion attempts or inadequate ventilation.

After failure of three attempts intubation will be performed using conventional rigid laryngoscopy and case will be recorded as failed.
15 minutes
Ease of insertion of device measured via VISUAL ANALOGUE SCALE
Time Frame: 15 minutes
The ease of insertion of device based on VISUAL ANALOGUE SCALE will be recorded.(0=easiest insertion of device,10=most difficult insertion)
15 minutes
Airway Sealing Pressure of device measured in mmHg
Time Frame: 15 minutes
The airway sealing pressure is measured at cuff pressure of 60 cmH2O by closing the expiratory valve of the circle system at a fixed gas flow of 3L/min and recording the airway pressure at which equilibrium is reached. At this stage a leak at mouth and stomach is ascertained.
15 minutes
Glottic View through the device measured in %
Time Frame: 10 minutes
Glottic viewing will be assessed by insertion of the fibreoptic bronchoscope through the airway channel of the respective SGA devices.
10 minutes
Number of attempts of gastric tube placement
Time Frame: 20 minutes
A maximum of two attempts were allowed for gastric tube placement. Its correct placement confirmed by injection of air and epigastric auscultation or aspiration of gastric contents. Failure was defined as inability to advance the orogastric tube into the stomach within two attempts.
20 minutes
Complications
Time Frame: 2hours
  • Note for any Blood staining of the device and tongue, lip and dental trauma.
  • Incidence of Laryngospasm in intra operative period will be noted and managed accordingly.
  • Sore Throat, Dysphagia and Hoarseness of voice.

In post-operative period an investigator blinded to study, will ask the patients about the signs of:

  1. Sore throat
  2. Dysphagia.
  3. Hoarseness of voice.

Sore throat will be assessed to a score of 0-3:

0: No pain

  1. Mild pain
  2. moderate pain
  3. Severe pain

Dysphagia and hoarseness in voice was assessed on a score of 0-1:

0: Absent

1: Present
2hours
Mean Blood Pressure measured in mmHg
Time Frame: 30 minutes
Preinsertion ,0,1,3,5 and 10 minutes post insertion
30 minutes
Heart Rate measured in beats per minute
Time Frame: 30 minutes
Preinsertion ,0,1,3,5 and 10 minutes post insertion
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr.Mahak Mehta

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 328/GMC/IEC/2016/Reg.No.280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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