AnaesthesiaNCT02197377
The Laryngeal Mask Airway in Edentulous Geriatric Patients
A study testing Group LMA Unique™ and Group LMA Supreme™ in people with Anaesthesia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Group LMA Unique™ and Group LMA Supreme™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2009to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ASA I-III
- 65 years and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Izmi̇r, Narlıdere, 35320
About this study
Official title: Comparison of The Laryngeal Mask Airway Supreme™ Versus Unique™ in Edentulous Geriatric Patients
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.
- Conditions
- Anaesthesia
- Being tested
- Group LMA Unique™, Group LMA Supreme™
- Keywords
- Laryngeal mask airway, edentulous geriatric patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group LMA Unique™Device
Also called Laryngeal Mask Airway Unique, LMA Unique (The Laryngeal Mask Company Limited, Singapore)
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.
Group LMA Supreme™Device
Also called Laryngeal Mask Airway Supreme, Teleflex, The Laryngeal Mask Company Limited, Singapore
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Group LMA Supreme™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt's Success Rate of Insertion
Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).
Measured: 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
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Ozbilgin, Dokuz Eylul University
- Investigators
- TANGUL KILIÇ, M.D., Principal investigator, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and ReanimationSEMİH KUCUKGUCLU, M.D., Study director, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197377
- Sponsor's protocol ID
- 178/2009
- Status last verified
- Dec 2017
- First submitted
- 21 Jul 2014
- Last updated
- 19 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Laryngeal Mask Airway Supreme™ Versus Unique™ in Edentulous Geriatric Patients
- ClinicalTrials.gov ID
- NCT02197377
- Acronym / sponsor ID
- 178/2009
- Conditions
- Anaesthesia
- Keywords
- Laryngeal mask airway, edentulous geriatric patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Posted 19 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group LMA Unique | Active comparator | Device: 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. |
| Group LMA Supreme | Experimental | Device: 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- ASA I-III
- 65 years and older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group LMA Unique™Also: Laryngeal Mask Airway Unique, LMA Unique (The Laryngeal Mask Company Limited, Singapore)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. | Device | Group LMA Unique |
| Group LMA Supreme™Also: Laryngeal Mask Airway Supreme, Teleflex, The Laryngeal Mask Company Limited, SingaporeThe 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. | Device | Group LMA Supreme |
Primary outcome
First Attempt's Success Rate of Insertion
Time frame: after anaesthesia induction
Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).
1 secondary outcome
Oropharyngeal Leak Pressure
Time frame: before surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group LMA Unique™ and Group LMA Supreme™ in people with Anaesthesia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Attempt's Success Rate of Insertion (time frame: after anaesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.