CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Laryngeal Mask Unique insertionother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02219282
NCT02219282N/ACompleted

A Comparison of Laryngeal Mask UniqueTM in Denticulate and Edentulate Geriatric Patients

Dokuz Eylul University·interventional·Posted Aug 18, 2014·Updated Jun 29, 2017

In Brief

A clinical study evaluating Laryngeal Mask Unique insertion for Anaesthesia. Completed, enrolled 66 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaesthesia
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2014
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.9 years ago

Interventions

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.