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N/A N=66 Double-blind Screening

Geriatric Patients and Laryngeal Mask Unique

Anaesthesia

Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Successful Laryngeal Mask Placement — 26; 20; 6; 11 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Laryngeal Mask Unique insertion (Other)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Dokuz Eylul University
Primary completion
Nov 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Successful Laryngeal Mask Placement
26; 20; 6; 11; 0; 1
SECONDARY
Oropharyngeal Leak Pressure
21.75; 20.75
SECONDARY
Haemodynamic Response to Insertion of Airway Device.
94.3; 95.1; 80.1; 80.2; 80.1; 79.2
SECONDARY
Ease of Placement Laryngeal Mask
30; 25; 2; 7
SECONDARY
Insertion Time of Laryngeal Mask
14.40; 13.43

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.

Eligibility Criteria

Inclusion Criteria

  • Above the age of 65
  • ASA I-III
  • Undergoing elective surgery

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02219282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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