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

NCT04045899 | Completed DMC

• 1 other identifier: 328/GMC/IEC/2016/Reg.No.280
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Comparison of device

Outcome Measures

Primary Outcomes (1)

• Insertion Time of device measured in seconds

  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 Outcomes (8)

• Number of attempts of insertion of device

  15 minutes

• Ease of insertion of device measured via VISUAL ANALOGUE SCALE

  15 minutes

• Airway Sealing Pressure of device measured in mmHg

  15 minutes

• Glottic View through the device measured in %

  10 minutes

• Number of attempts of gastric tube placement

  20 minutes

Study Arms (3)

ProSeal Laryngeal Mask Airway Group

ACTIVE COMPARATOR

ProSeal LMA was inserted in 50 patients

Device: Proseal LMA

Air-Q LMA Group

EXPERIMENTAL

Air-Q LMA was inserted in 50 patients

Device: Air-Q LMA

Ambu AuraGain LMA Group

EXPERIMENTAL

Ambu AuraGain was inserted in 50 patients

Device: Ambu AuraGain LMA

Interventions

Proseal LMA DEVICE

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.

ProSeal Laryngeal Mask Airway Group

Air-Q LMA DEVICE

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.

Air-Q LMA Group

Ambu AuraGain LMA DEVICE

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.

Ambu AuraGain LMA Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr.Mahak Mehta: lead

Related Publications (19)

• 1. Sood J. Laryngeal mask airway and its variants. Indian J Anaesth. 2005;49(4):275-80.

  BACKGROUND

• Singh K, Gurha P. Comparative evaluation of Ambu AuraGain with ProSeal laryngeal mask airway in patients undergoing laparoscopic cholecystectomy. Indian J Anaesth. 2017 Jun;61(6):469-474. doi: 10.4103/ija.IJA_163_17.

  PMID: 28655951 BACKGROUND

• Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.

  PMID: 20540172 BACKGROUND

• 13. Soliman HF. Insertion characteristics of three supraglottic airway devices: A randomized comparative trial. Ain-Shams J Anaesthesiol. 2016;9(2):212-8.

  BACKGROUND

• 14.Abdel-Halim TM, El Enin MA, Elgoushi MM, Afifi MG, Atwa HS. Comparative study between Air-Q and Intubating Laryngeal Mask Airway when used as conduit for fiber-optic. Egyptian J Anaesth. 2014;30(2):107-13.

  BACKGROUND

• Brimacombe J, Keller C. The ProSeal laryngeal mask airway. Anesthesiol Clin North Am. 2002 Dec;20(4):871-91. doi: 10.1016/s0889-8537(02)00044-5.

  PMID: 12512267 BACKGROUND

• Brimacombe J, Keller C, Boehler M, Puhringer F. Positive pressure ventilation with the ProSeal versus classic laryngeal mask airway: a randomized, crossover study of healthy female patients. Anesth Analg. 2001 Nov;93(5):1351-3, table of contents. doi: 10.1097/00000539-200111000-00064.

  PMID: 11682428 BACKGROUND

• Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.

  PMID: 21880031 RESULT

• Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Gebhardt ER, Johnson K, De Oliveira GS. A randomised comparison of the Ambu(R) AuraGain and the LMA(R) supreme in infants and children. Anaesthesia. 2016 Feb;71(2):205-12. doi: 10.1111/anae.13330. Epub 2015 Dec 9.

  PMID: 26648173 RESULT

• 4. Youssef MM, Lofty M, Hammad Y, Elmenshawy E. Comparative study between LMA-Proseal™ and Air-Q® Blocker for ventilation in adult eye trauma patients. Egyptian J Anaesth. 2014;30(3):227-33.

  RESULT

• 5. Sethi S, Maitra S, Saini V, Samara T. Comparison of Ambu® AuraGain™ laryngeal mask and air-Q™ intubating laryngeal airway for blind tracheal intubation in adults: a randomized controlled trial. Egyptian J Anaesthes. 2017;33(2):137-40.

  RESULT

• Joshi R, Rudingwa P, Kundra P, Panneerselvam S, Mishra SK. Comparision of Ambu AuraGain and LMA(R) ProSeal in children under controlled ventilation. Indian J Anaesth. 2018 Jun;62(6):455-460. doi: 10.4103/ija.IJA_86_18.

  PMID: 29962528 RESULT

• Brimacombe J, Keller C, Fullekrug B, Agro F, Rosenblatt W, Dierdorf SF, Garcia de Lucas E, Capdevilla X, Brimacombe N. A multicenter study comparing the ProSeal and Classic laryngeal mask airway in anesthetized, nonparalyzed patients. Anesthesiology. 2002 Feb;96(2):289-95. doi: 10.1097/00000542-200202000-00011.

  PMID: 11818758 RESULT

• Parikh DA, Jain RA, Lele SS, Tendolkar BA. A cohort evaluation of clinical use and performance characteristics of Ambu(R) AuraGain: A prospective observational study. Indian J Anaesth. 2017 Aug;61(8):636-642. doi: 10.4103/ija.IJA_285_17.

  PMID: 28890558 RESULT

• Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26.

  PMID: 29582360 RESULT

• 11. Bhandari G, Mitra S, Shahi KS, Chand G, Tyagi A. A comparative study evaluating I-gel and Air-Q LMA for ventilation in anaesthetised and paralysed patients. Ann Int Med Dent Res. 2015;32:25-8.

  RESULT

• Lopez AM, Agusti M, Gambus P, Pons M, Anglada T, Valero R. A randomized comparison of the Ambu AuraGain versus the LMA supreme in patients undergoing gynaecologic laparoscopic surgery. J Clin Monit Comput. 2017 Dec;31(6):1255-1262. doi: 10.1007/s10877-016-9963-0. Epub 2016 Nov 26.

  PMID: 27889843 RESULT

• Darlong V, Biyani G, Pandey R, Baidya DK, Punj Ca. Comparison of performance and efficacy of air-Q intubating laryngeal airway and flexible laryngeal mask airway in anesthetized and paralyzed infants and children. Paediatr Anaesth. 2014 Oct;24(10):1066-71. doi: 10.1111/pan.12462.

  PMID: 24961960 RESULT

• 19. Lopez AM, Sala-Blanch X, Valero R, Prats A. Cross-over assessment of the AmbuAuraGain, LMA Supreme New Cuff and Intersurgical I-Gel in fresh cadavers. Open J Anesthesiol. 2014;4(12):332-9.

  RESULT

Study Officials

• MAHAK MEHTA, MD

  M.B.B.S M.D Anaesthesia GMC Haldwani(Nainital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: POST GRADUATE STUDENT

Model Details: Methods:This prospective, randomised, single-blind study was conducted on 150 American Society of Anesthesiologists physical status I-II, randomly allocated into 3 groups, undergoing elective surgical procedures under general anaesthesia.PLMATM, Air-Q® and Ambu AuraGainTM appropriate for weight or/and height was inserted.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 recorded.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: August 6, 2019
• Study Start: November 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share