AnaesthesiaNCT02219282
Geriatric Patients and Laryngeal Mask Unique
A study testing Laryngeal Mask Unique insertion in people with Anaesthesia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
As a result of rises in living standards quality of life is progressively increasing. Combined with developments in anesthesia, surgical techniques and medication allowing more difficult and complicated interventions to be carried out, elderly patients are encountered more often in daily anesthetic practice.Reduced… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Laryngeal Mask Unique insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2010to Dec 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
- Above the age of 65
- ASA I-III
- Undergoing elective surgery
Who cannot join
- Patients with recent history of upper respiratory infection
- Obese patients with body-mass index above 35 kg/m2
- Symptomatic hiatus hernia
- Severe gastroesophageal reflux
- 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: A Comparison of Laryngeal Mask UniqueTM in Denticulate and Edentulate Geriatric Patients
As a result of rises in living standards quality of life is progressively increasing. Combined with developments in anesthesia, surgical techniques and medication allowing more difficult and complicated interventions to be carried out, elderly patients are encountered more often in daily anesthetic practice.Reduced tone in the upper airway of geriatric patients increases the possibility of airway obstruction. In old patients with no teeth, sunken cheeks may make ventilation with a mask ineffective; perhaps even impossible.
In addition to our observations that Laryngeal mask (LM) is more difficult to place in older patients, in the literature there are very few studies on the use of LM in older patients. Sixty percent of patients over the age of 65 have no teeth. Ventilation with a mask is more difficult for patients without teeth compared to those with teeth. Laryngeal mask is an alternative airway device for patients without teeth when the face mask does not sit correctly.
The aim of this study is primarily to measure the success of placement on first try, ease and duration of insertion and oropharyngeal leak pressure of laryngeal mask Unique (LMU) in patients 65 years of age and above dentulous and edentulous elderly patients. The secondary aim is to compare the effects on the hemodynamic response occurring during placement.
Read the detailed description
This study received permission from Dokuz Eylül University Medical Faculty Ethics Committee and informed consent was obtained from the patients. Sixty-six patients above the age of 65 with American Society of Anesthesiologists (ASA) physiological classification group I-III, undergoing elective surgery and with indications for laryngeal mask placement participated in this prospective, and double bland study.
Patients taken to the operating room were monitored for heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), electrocardiography (ECG-Derivation II), and peripheral oxygen saturation (SpO2) before anesthesia induction. Depth of anesthesia was evaluated with a bispectral index monitor. The patients were preoxygenated with 6 L.min-1 oxygen through a face mask for 3 minutes. For anesthesia induction 0.02 mg.kg-1 midazolam, 1-2 μg.kg-1 fentanyl and 1-2 mg.kg-1 propofol were used. Afterwards patients were given mask ventilation with 100% oxygen. Before laryngeal masks were inserted they were prepared by being lubricated with water-based gel and the cuffs were completely deflated.
After induction agents were administered when BIS values were between 40-60 and sufficient chin relaxation was obtained LMU was inserted according to the standard methods determined by Brain. The LMU size was chosen based on the patient's body weight; those from 30-50 kg used no. 3, from 50-70 kg used no. 4 and those from 70-100 kg used no 5 LMU. During attempts depending on the patient reaction and to keep the BIS values 40-60, an additional dose of 0.5 mg/kg propofol was administered.
The cuffs of the laryngeal mask were inflated and held at 60 centimeters of water. After the operation before the LM was removed the cuff inner pressure was measured again and recorded. The success of the first attempt at insertion of the laryngeal mask was recorded. During placement in cases with 3 unsuccessful attempts, patients were intubated to provide airway management.
Anesthesia was maintained with a 50% O2/air mix with 1.5-2.5% sevoflurane. Concentration of sevoflurane was set to keep the bispectral index value below 40.
Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) and bispectral index values (BIS) were recorded before anesthesia induction, before LM insertion and in the 1st, 2nd, 3rd and 5th minutes after LM insertion was confirmed.
The time for successful insertion was defined as the duration from mouth opening to first successful ventilation and recorded. The number of insertion attempts and ease of insertion were recorded.
Criteria indicating successful laryngeal mask placement:
- Waves with square shape on capnogram
- Easy ventilation with respiration balloon and observed chest movement
- No ventilation leak with approximately 20 centimeters of water positive pressure Evaluation of ease of insertion based on likert scala (1-4 point from easy to unsuccessful).
After laryngeal mask insertion, the oropharyngeal leak test was conducted by a researcher unaware of whether the patients had teeth or not. To complete the test after the expiring valve was shut fresh gas flow was reduced to 3 L.min-1. When the sound of a leak was heard from the mouth the airway pressure value (OLP) was recorded. During this test airway pressure was not allowed to rise above 40 centimeters of water. From the start of the operation to the end, the patients were monitored for hypoxia (SpO2 falling below 90%) and laryngospasm. In cases where the third attempt at LM insertion was unsuccessful, if the SpO2 values fell below 90% at any time in the study or if laryngospasm developed, the patients were excluded from the study.
The duration of use of laryngeal mask (duration from insertion to removal) in both groups were recorded. After the laryngeal mask was removed it was evaluated for traces of blood. When leaving the recovery unit and 24 hours later throat pain, dysphonia and dysphagia were evaluated. Throat pain was evaluated using the VAS-10 (visual analogue scale).
- Conditions
- Anaesthesia
- Being tested
- Laryngeal Mask Unique insertion
- Keywords
- laryngeal mask airway, edentulate geriatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask Unique insertionOther
Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
| Study group | Role | What they receive |
|---|---|---|
| Group Dentulous | Active comparator | Laryngeal Mask Unique insertion Receives: Other: Laryngeal Mask Unique insertion |
| Group Edentulous | Experimental | Laryngeal Mask Unique insertion Receives: Other: Laryngeal Mask Unique insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Laryngeal Mask Placement
The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.
Measured: Baseline
Secondary outcomes (4)
Oropharyngeal Leak Pressure
Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.
Measured: Baseline
Haemodynamic Response to Insertion of Airway Device.
Mean blood pressure (MBP) (mmHg) were recorded in both groups.
Measured: Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertion
Ease of Placement Laryngeal Mask
Ease (according to Likert scale 1-4 point from easy to diffucult).
Measured: During Laryngeal mask placement
Insertion Time of Laryngeal Mask
Duration of insertion (second) Laryngeal Mask;second
Measured: During placement of Laryngeal Mask
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionDec 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 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
- SEMİH KUCUKGUCLU, M.D., Study director, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219282
- Sponsor's protocol ID
- 2010/08-15
- Status last verified
- May 2017
- First submitted
- 31 Jul 2014
- Last updated
- 29 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Laryngeal Mask UniqueTM in Denticulate and Edentulate Geriatric Patients
- ClinicalTrials.gov ID
- NCT02219282
- Acronym / sponsor ID
- 2010/08-15
- Conditions
- Anaesthesia
- Keywords
- laryngeal mask airway, edentulate geriatric patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Posted 29 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a result of rises in living standards quality of life is progressively increasing. Combined with developments in anesthesia, surgical techniques and medication allowing more difficult and complicated interventions to be carried out, elderly patients are encountered more often in daily anesthetic practice.Reduced tone in the upper airway of geriatric patients increases the possibility of airway obstruction. In old patients with no teeth, sunken cheeks may make ventilation with a mask ineffective; perhaps even impossible.
In addition to our observations that Laryngeal mask (LM) is more difficult to place in older patients, in the literature there are very few studies on the use of LM in older patients. Sixty percent of patients over the age of 65 have no teeth. Ventilation with a mask is more difficult for patients without teeth compared to those with teeth. Laryngeal mask is an alternative airway device for patients without teeth when the face mask does not sit correctly.
The aim of this study is primarily to measure the success of placement on first try, ease and duration of insertion and oropharyngeal leak pressure of laryngeal mask Unique (LMU) in patients 65 years of age and above dentulous and edentulous elderly patients. The secondary aim is to compare the effects on the hemodynamic response occurring during placement.
Detailed description
This study received permission from Dokuz Eylül University Medical Faculty Ethics Committee and informed consent was obtained from the patients. Sixty-six patients above the age of 65 with American Society of Anesthesiologists (ASA) physiological classification group I-III, undergoing elective surgery and with indications for laryngeal mask placement participated in this prospective, and double bland study.
Patients taken to the operating room were monitored for heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), electrocardiography (ECG-Derivation II), and peripheral oxygen saturation (SpO2) before anesthesia induction. Depth of anesthesia was evaluated with a bispectral index monitor. The patients were preoxygenated with 6 L.min-1 oxygen through a face mask for 3 minutes. For anesthesia induction 0.02 mg.kg-1 midazolam, 1-2 μg.kg-1 fentanyl and 1-2 mg.kg-1 propofol were used. Afterwards patients were given mask ventilation with 100% oxygen. Before laryngeal masks were inserted they were prepared by being lubricated with water-based gel and the cuffs were completely deflated.
After induction agents were administered when BIS values were between 40-60 and sufficient chin relaxation was obtained LMU was inserted according to the standard methods determined by Brain. The LMU size was chosen based on the patient's body weight; those from 30-50 kg used no. 3, from 50-70 kg used no. 4 and those from 70-100 kg used no 5 LMU. During attempts depending on the patient reaction and to keep the BIS values 40-60, an additional dose of 0.5 mg/kg propofol was administered.
The cuffs of the laryngeal mask were inflated and held at 60 centimeters of water. After the operation before the LM was removed the cuff inner pressure was measured again and recorded. The success of the first attempt at insertion of the laryngeal mask was recorded. During placement in cases with 3 unsuccessful attempts, patients were intubated to provide airway management.
Anesthesia was maintained with a 50% O2/air mix with 1.5-2.5% sevoflurane. Concentration of sevoflurane was set to keep the bispectral index value below 40.
Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) and bispectral index values (BIS) were recorded before anesthesia induction, before LM insertion and in the 1st, 2nd, 3rd and 5th minutes after LM insertion was confirmed.
The time for successful insertion was defined as the duration from mouth opening to first successful ventilation and recorded. The number of insertion attempts and ease of insertion were recorded.
Criteria indicating successful laryngeal mask placement:
- Waves with square shape on capnogram
- Easy ventilation with respiration balloon and observed chest movement
- No ventilation leak with approximately 20 centimeters of water positive pressure Evaluation of ease of insertion based on likert scala (1-4 point from easy to unsuccessful).
After laryngeal mask insertion, the oropharyngeal leak test was conducted by a researcher unaware of whether the patients had teeth or not. To complete the test after the expiring valve was shut fresh gas flow was reduced to 3 L.min-1. When the sound of a leak was heard from the mouth the airway pressure value (OLP) was recorded. During this test airway pressure was not allowed to rise above 40 centimeters of water. From the start of the operation to the end, the patients were monitored for hypoxia (SpO2 falling below 90%) and laryngospasm. In cases where the third attempt at LM insertion was unsuccessful, if the SpO2 values fell below 90% at any time in the study or if laryngospasm developed, the patients were excluded from the study.
The duration of use of laryngeal mask (duration from insertion to removal) in both groups were recorded. After the laryngeal mask was removed it was evaluated for traces of blood. When leaving the recovery unit and 24 hours later throat pain, dysphonia and dysphagia were evaluated. Throat pain was evaluated using the VAS-10 (visual analogue scale).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dentulous | Active comparator | Other: Laryngeal Mask Unique insertionLaryngeal Mask Unique insertion |
| Group Edentulous | Experimental | Other: Laryngeal Mask Unique insertionLaryngeal Mask Unique insertion |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Above the age of 65
- ASA I-III
- Undergoing elective surgery
Key exclusion criteria (6 listed)
- Patients with recent history of upper respiratory infection
- Obese patients with body-mass index above 35 kg/m2
- Symptomatic hiatus hernia
- Severe gastroesophageal reflux
- Those with low pulmonary compliance or high airway resistance (morbid obesity, lung disease)
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 |
|---|---|---|
| Laryngeal Mask Unique insertionBefore insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience. | Other | Group Dentulous, Group Edentulous |
Primary outcome
Number of Participants With Successful Laryngeal Mask Placement
Time frame: Baseline
The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.
4 secondary outcomes
Oropharyngeal Leak Pressure
Time frame: Baseline
Haemodynamic Response to Insertion of Airway Device.
Time frame: Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertion
Ease of Placement Laryngeal Mask
Time frame: During Laryngeal mask placement
Insertion Time of Laryngeal Mask
Time frame: During placement of Laryngeal Mask
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- 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.
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 Laryngeal Mask Unique insertion 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 3 inclusion and 6 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 29 Jun 2017. 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 29 Jun 2017). 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?
Number of Participants With Successful Laryngeal Mask Placement (time frame: Baseline). 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 29 Jun 2017.