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The Laryngeal Mask Airway in Edentulous Geriatric Patients

Comparison of The Laryngeal Mask Airway Supreme™ Versus Unique™ in Edentulous Geriatric Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02197377
Enrollment
60
Registered
2014-07-22
Start date
2009-08-31
Completion date
2010-05-31
Last updated
2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Keywords

Laryngeal mask airway, edentulous geriatric patient

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.

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.

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.

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.

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ASA I-III * 65 years and older

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

Design outcomes

Primary

MeasureTime frameDescription
First Attempt's Success Rate of Insertionafter anaesthesia inductionEdentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).

Secondary

MeasureTime frameDescription
Oropharyngeal Leak Pressurebefore surgeryThe aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
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. Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.
30
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. Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.
27
Total57

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyInsertion Failure03

Baseline characteristics

CharacteristicGroup LMA UniqueGroup LMA SupremeTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
30 Participants27 Participants57 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Region of Enrollment
Turkey
30 participants27 participants57 participants
Sex: Female, Male
Female
9 Participants11 Participants20 Participants
Sex: Female, Male
Male
21 Participants16 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 27
other
Total, other adverse events
0 / 300 / 27
serious
Total, serious adverse events
0 / 300 / 27

Outcome results

Primary

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

Population: Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P \< 0.05 was considered significant. 3 LMA insertion failed in Group LMA Supreme. Total 27 patients included analysis.

ArmMeasureValue (NUMBER)
Group LMA UniqueFirst Attempt's Success Rate of Insertion73.3 percentage of participants
Group LMA SupremeFirst Attempt's Success Rate of Insertion86.6 percentage of participants
Secondary

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

Population: Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P \< 0.05 was considered significant.

ArmMeasureValue (MEAN)Dispersion
Group LMA UniqueOropharyngeal Leak Pressure17.1 cm H20Standard Deviation 6.33
Group LMA SupremeOropharyngeal Leak Pressure20.56 cm H20Standard Deviation 8.22

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026