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CompletedNCT02197377Updated Oct 19, 2018Results posted

The Laryngeal Mask Airway in Edentulous Geriatric Patients

An interventional study of Group LMA Unique™ and Group LMA Supreme™ in Anaesthesia, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-10-19.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

After Ethical Committee approval and written informed consent were obtained, sixty edentulous patients (American Society of Anesthesiologists physical status (ASA) grade I-III, aged over 65 years) undergoing elective surgery were included into the study. Patients with dentures had to remove their dentures before surgery at the ward. The supraglottic airway device was inserted into each patient in a random order. A statistician independent of the clinical investigators generated the randomization sequence using a computerized program. Patients were excluded if they had a known or predicted difficult airway, a body mass index > 35 kg/m2, or were at risk of aspiration. All cases were conducted by anesthetists who had experience over 5 years of LMA insertion.

Demographic parameters, Mallampati classification and the duration of surgery were recorded. Patients were routinely monitored using ECG, non-invasive blood pressure measurement, pulse oximetry and end-tidal carbon dioxide tension. Depth of anesthesia was monitored with bispectral index (BIS).

Patients were premedicated with midazolam 0.02 mg/kg when venous access was obtained. After 3 min preoxygenation with 100 % oxygen via face mask, anesthesia was induced with fentanyl 1-2 µg/kg and propofol 1-2 mg/kg. When the BIS value was 40-60 the predetermined supraglottic airway device was inserted according to the manufacturer's recommendations. 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.

An effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace. General anesthesia was maintained with sevoflurane, O2 and N2O.

Insertion time was defined as the time from picking up the airway device until connection to the airway circuit. Ease of insertion was graded by the attending anesthesiologist as easy, fair or difficult. If after three attempts insertion was still not successful, the other device was used. If insertion of the other device also failed the patient was endotracheally intubated.

Before the oropharyngeal leak test was carried out, the face of the patient was covered so that the observer was blinded to the airway device. 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.

After successful placement of the LMA Supreme™, a 12 French gauge gastric catheter was inserted via the gastric channel.

Any episode of hypoxemia (SpO2 \< 90%), aspiration or regurgitation,bronchospasm and airway obstruction were documented. After removal of the LMA, it was examined for the presence of visible blood.

In the postanesthesia care unit, a research assistant, who was blinded to the group allocation, interviewed the patients using a predetermined questionnaire to collect data on the postoperative pharyngolaryngeal adverse events. The presence or absence of sore throat, dysphonia and dysphagia was assessed at 1 and 24 h postoperatively.

02

Conditions studied

  • Anaesthesia

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Keywords

  • Laryngeal mask airway, edentulous geriatric patient
03

In context

Mouth, Edentulous

244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.

This study's enrollment of 60 is above the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.

Browse Mouth, Edentulous studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA I-III
  • 65 years and older

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Group LMA Unique

    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™

  • Experimental
    Group LMA Supreme

    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

  • DeviceGroup LMA Unique™

    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)

  • DeviceGroup LMA Supreme™

    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

06

What researchers measure

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).

    Time frame: after anaesthesia induction

Secondary outcomes

  1. Oropharyngeal Leak Pressure

    The aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications

    Time frame: before surgery

07

Results

Posted Oct 19, 2018

Participant flow

Participant flow — Overall Study
MilestoneGroup LMA UniqueGroup LMA Supreme
Started3030
Completed3027
Not completed03
Withdrew: Insertion failure03

Outcome measures

PrimaryFirst Attempt's Success Rate of Insertion

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

Time frame:
after anaesthesia induction
Reported as:
Number · percentage of participants
First Attempt's Success Rate of Insertion
percentage of participantsGroup LMA UniqueGroup LMA Supreme
First Attempt's Success Rate of Insertion73.386.6
SecondaryOropharyngeal Leak Pressure

The aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications

Time frame:
before surgery
Reported as:
Mean · cm H20
Oropharyngeal Leak Pressure
cm H20Group LMA UniqueGroup LMA Supreme
Oropharyngeal Leak Pressure17.1 ± 6.3320.56 ± 8.22

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group LMA Unique0/30 (0%)0/30 (0%)0/30 (0%)
Group LMA Supreme0/27 (0%)0/27 (0%)0/27 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group LMA UniqueGroup LMA SupremeTotal
<=18 years000
Between 18 and 65 years000
>=65 years302757
Sex: Female, Male
Sex: Female, Male(Participants)Group LMA UniqueGroup LMA SupremeTotal
Female91120
Male211637
Region of Enrollment
Region of Enrollment(participants)Group LMA UniqueGroup LMA SupremeTotal
Turkey302757
08

Study locations

1 site
  • Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
    Izmi̇r, Narlıdere 35320, Turkey
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02197377
Lead sponsor
Dokuz Eylul University
Responsible party
Sule Ozbilgin (Anaesthesiology and Reanimation, Dokuz Eylul University) — Principal investigator
First posted
Jul 22, 2014
Start date
Aug 2009
Primary completion
Apr 2010
Completion
May 2010
Results posted
Oct 19, 2018
Last update
Oct 19, 2018

Study contacts

TANGUL KILIÇ, M.D.
principal investigator · Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
SEMİH KUCUKGUCLU, M.D.
study director · Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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