Three Inflation Methods of the Ambú Auraonce™ and Its Adverse Effects

NCT04769791 | Completed

• 1 other identifier: Idipaz 4888
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Laryngeal mask airway device (LMA) is a common device used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use, probably because of a rapid increase of ambulatory surgical procedures and also due to the development of procedures in areas away from the operating room. The cuff inflating volume is not standardized and it is common practice to inflate the LMA cuff according to the manufacturer's recommendations, without using a manometer. A hyperinflation of the LMA 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 AuraOnce™ LMA during fibrobronchoscopy 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 (NVgroup)

Conditions

Laryngeal Mask Airway

Keywords

laryngeal mask; intracuff pressure; sore throat

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.

Device: 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):

Device: intracuff pressure measurement

unchanged cuff inflation volume

EXPERIMENTAL

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

Device: intracuff pressure measurement

Interventions

intracuff pressure measurement DEVICE

intracuff pressure is measured by a pressure manometer

cuff inflation by the residual 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 Anesthesiologists (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 (\< 3 cm of interincisal distance)
• patients with any pathology of the neck, upper respiratory or upper alimentary tract
• BMI \> 40 Kilogram / m2
• 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

• Prim T, Brogly N, Guasch E, Diez J, Gilsanz F. Efficacy and safety of three inflation methods of the laryngeal mask airway Ambu(R) Auraonce: a randomized controlled study. J Clin Monit Comput. 2024 Feb;38(1):37-45. doi: 10.1007/s10877-023-01061-x. Epub 2023 Aug 4.

  PMID: 37540323 DERIVED

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

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: February 12, 2021
• First Posted: February 25, 2021
• Study Start: July 17, 2017
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

ES (1)