Three Inflation Methods of Ambú Auragain™ and Its Adverse Effects

NCT04795544 | Completed

• 1 other identifier: idipaz 5735
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Laryngeal mask is a common supraglottic device (SGD) used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use. At the moment, the SGD is being used in several situations, which include general anesthesia, cardiopulmonary resuscitation, and difficult airway management. To insert the SGD safely in these situations, the Fourth National Audit Project has encouraged the use of second-generation SGD equipped with the passage of a nasogastric tube. Ambu Auragain™ is a recent second-generation SGD with an incorporated gastric drainage channel and the capability of working as a conduit for tracheal intubation. It has higher leak pressure than the ones of first generation, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway. However, there are still few reports of which volume of cuff is the most appropriate for it use. The cuff inflating volume is not standardized and it is common practice to inflate the SGD cuff according to the manufacturer's recommendations, without using a manometer. A hyperinflation of the laryngeal mask cuff was associated with complications ranging from sore throat, or dysphagia and dysphonia, to more serious complications such as paralysis of the vocal cord, arytenoid cartilages dislocation, recurrent laryngeal nerve injury and hypoglossal nerve injury. Also, the excess of volume or pressure is related to poor ventilation and increase the risk of gastric insufflation. The aim of this study is to evaluate the best cuff inflation method, in order to limit the intracuff pressure beyond the recommended maximum pressure (PM \< 60 cmH2O) and to allows decrease the pharyngo-laryngeal complications. The Primary outcome is to compare three different cuff inflating methods using Auragain™ laryngeal mask during fibro bronchoscopy and endobronchial ultrasound (EBUS) procedures, and to control the intracuff pressure, and the effect on pharyngo-laryngeal complications. The three different cuff inflating methods are: 1) residual volume group (RV group ) 2) half of the maximum volume group (MV group) 3) unchanged volume group (NV group)

Conditions

Laryngeal Mask Airway

Keywords

laryngeal mask; intracuff pressure; sore throat; oropharyngeal leak pressure

Outcome Measures

Primary Outcomes (1)

• intracuff pressure

  Compare Intracuff Pressure of three different cuff inflating volume methods with laryngeal mask, to control the intracuff pressure

  procedure ( after correct placement of SGD)

Secondary Outcomes (5)

• time of insertion

  procedure ( from pick up to correct placement of SGD

• insertion attempts

  procedure ( from pick up to correct placement of SGD

• OLP

  procedure ( after correct placement of SGD)

• positioning of the LMA

  procedure (after correct placement of SGD)

• pharyngolaryngeal complications

  day 2

Study Arms (3)

cuff inflation by the residual volume

EXPERIMENTAL

LMA will be inserted with the initial inflating volume correspondent to residual volume group (RV group): volume result of equilibrating pressure between intracuff pressure and atmospheric pressure. A 20 mL syringe without plunger is connected to the laryngeal cuff for 5 minutes

Procedure: Intracuff pressure measurement

cuff inflation by half of the maximum volume

EXPERIMENTAL

LMA will be inserted with the initial inflating volume correspondent to half of the maximum volume recommended by manufacturers (MV group)

Procedure: Intracuff pressure measurement

unchanged cuff inflation volume

PLACEBO COMPARATOR

LMA will be inserted unchanged (NV group): LMA is unpacked and used without inflating or deflating the cuff.

Procedure: Intracuff pressure measurement

Interventions

Intracuff pressure measurement PROCEDURE

Intracuff pressure is measured by a pressure manometer.

cuff inflation by half of the maximum volume; cuff inflation by the residual volume; unchanged cuff inflation volume

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age between 18 and 90 years
• American Society of Anesthesiologist (ASA) physical status I-III
• fiberoptic bronchoscopy procedure and EBUS-TBNA procedure programmed.
• Fasted for 6 hours before procedure.
• Management of the airway for the same anesthetic.
• Use de laryngeal mask airway for boarding and maintenance of airway permeability.

You may not qualify if:

• LMA is contraindicated because high risk of aspiration (full stomach, gastroesophageal reflux history, pregnant)
• predictors of difficult airway such restricted mouth opening (\< 2 cm of interincisal distance)
• patients with any pathology of the neck, upper respiratory or upper alimentary tract
• dysphagia o hoarseness.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Teresa Prim Martinez

Madrid, 28034, Spain

Location

Related Publications (6)

• Seet E, Yousaf F, Gupta S, Subramanyam R, Wong DT, Chung F. Use of manometry for laryngeal mask airway reduces postoperative pharyngolaryngeal adverse events: a prospective, randomized trial. Anesthesiology. 2010 Mar;112(3):652-7. doi: 10.1097/ALN.0b013e3181cf4346.

  PMID: 20179502 BACKGROUND

• Ghai B, Sethi S, Ram J, Wig J. Cuff filling volumes for pediatric classic laryngeal mask airways: comparison of clinical end points versus adjusted cuff pressure. Paediatr Anaesth. 2013 Feb;23(2):122-6. doi: 10.1111/pan.12023. Epub 2012 Sep 18.

  PMID: 22985184 BACKGROUND

• Keller C, Puhringer F, Brimacombe JR. Influence of cuff volume on oropharyngeal leak pressure and fibreoptic position with the laryngeal mask airway. Br J Anaesth. 1998 Aug;81(2):186-7. doi: 10.1093/bja/81.2.186.

  PMID: 9813520 BACKGROUND

• Li BB, Yan J, Zhou HG, Hao J, Liu AJ, Ma ZL. Application of Minimum Effective Cuff Inflating Volume for Laryngeal Mask Airway and its Impact on Postoperative Pharyngeal Complications. Chin Med J (Engl). 2015 Oct 5;128(19):2570-6. doi: 10.4103/0366-6999.166034.

  PMID: 26415792 BACKGROUND

• Ruananukun N, Watcharotayangul J, Jeeranukosol S, Komonhirun R. Correlation and variation of cuff inflating volumes and pressures in different adult models of laryngeal mask: a prospective randomized trial. BMC Anesthesiol. 2020 May 7;20(1):108. doi: 10.1186/s12871-020-01028-4.

  PMID: 32380954 BACKGROUND

• Shariffuddin II, Teoh WH, Tang E, Hashim N, Loh PS. Ambu(R) AuraGain versus LMA Supreme Second Seal: a randomised controlled trial comparing oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients. Anaesth Intensive Care. 2017 Mar;45(2):244-250. doi: 10.1177/0310057X1704500215.

  PMID: 28267947 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• TERESA PRIM MARTINEZ, MD

  HOSPITAL La Paz

  PRINCIPAL INVESTIGATOR

• NICOLÁS BROGLY, MD

  Hospital La Paz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 12, 2021
• Study Start: January 18, 2021
• Primary Completion: October 20, 2021
• Study Completion: October 30, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

ES (1)