The Laryngeal Mask Airway in Edentulous Geriatric Patients

NCT02197377 | Completed Results

• 1 other identifier: 178/2009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

With an aging population a prevalence of edentulous patients increased above 60 % among individuals aged ≥65 yr. Face mask ventilation of these edentulous patients is often difficult because of the inadequate fitting of the standard mask to the face. In addition, because of a reduction in muscle tone under general anesthesia, the air space in the oropharynx is reduced, and posterior displacement of the tongue, soft palate and epiglottis tend to close the airway. The laryngeal mask airway (LMA) provides a better alternative to the standard face mask if the facial contours of the patient are not suited to the standard face mask. It is more difficult to perform bag-mask ventilation in edentulous patients than in patients with intact dentition. The laryngeal mask airway (LMA) provides a better alternative to the standard face mask if the facial contours of the patient are not suited to the standard face mask. We aimed to compare the routinely used laryngeal mask airway in our clinic, the LMA Unique™ with the newly released LMA Supreme™ in edentulous elderly patients for the success in first attempt insertion, ease and time of insertion, and oropharyngeal leak pressure.

Conditions

Anaesthesia

Keywords

Laryngeal mask airway, edentulous geriatric patient

Outcome Measures

Primary Outcomes (1)

• First Attempt's Success Rate of Insertion

  Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).

  after anaesthesia induction

Secondary Outcomes (1)

• Oropharyngeal Leak Pressure

  before surgery

Study Arms (2)

Group LMA Unique

ACTIVE COMPARATOR

The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.The oropharyngeal leak pressure was determined by transiently stopping ventilation and closing the adjustable pressure-limiting valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.

Device: Group LMA Unique™

Group LMA Supreme

EXPERIMENTAL

The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.The oropharyngeal leak pressure was determined by transiently stopping ventilation and closing the adjustable pressure-limiting valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.

Device: Group LMA Supreme™

Interventions

Group LMA Unique™ DEVICE

The supraglottic airway devices were deflated fully before insertion. After placement an effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace.

Also known as: Laryngeal Mask Airway Unique, LMA Unique (The Laryngeal Mask Company Limited, Singapore)

Group LMA Unique

Group LMA Supreme™ DEVICE

The supraglottic airway devices were deflated fully before insertion.The supraglottic airway devices were deflated fully before insertion. After placement an effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace.

Also known as: Laryngeal Mask Airway Supreme, Teleflex, The Laryngeal Mask Company Limited, Singapore

Group LMA Supreme

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ASA I-III
• years and older

You may not qualify if:

• Any neck or upper respiratory pathology
• Those at risk of gastric content regurgitation/aspiration (previous upper gastro-intestina system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
• Possibility of and those with history of difficult intubation (history of impossible intubation, Mallampati classification 3-4, sterno mental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm)
• Those with low pulmonary compliance or high airway resistance (morbid obesity, lung disease)
• Throat pain, dysphagia and dysphonia

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Izmi̇r, Narlıdere, 35320, Turkey (Türkiye)

Location

Results Point of Contact

• Title: Anaesthesiology and Reanimation
• Organization: DorkuzEU

ozbilginsule@gmail.com

0905055252901

Study Officials

• TANGUL KILIÇ, M.D.

  Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

• SEMİH KUCUKGUCLU, M.D.

  Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiology and Reanimation

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 22, 2014
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2017-12

Locations

TU (1)