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Geriatric Patients and Laryngeal Mask Unique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219282
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sule Ozbilgin, Dokuz Eylul University

Brief 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.


Condition or disease Intervention/treatment Phase
Anaesthesia Other: Laryngeal Mask Unique insertion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: A Comparison of Laryngeal Mask UniqueTM in Denticulate and Edentulate Geriatric Patients
Study Start Date : August 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: Group Dentulous
Laryngeal Mask Unique insertion
Other: Laryngeal Mask Unique insertion
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.

Experimental: Group Edentulous
Laryngeal Mask Unique insertion
Other: Laryngeal Mask Unique insertion
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Oropharyngeal Leak Pressure [ Time Frame: Baseline ]
    Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.

  2. 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 ]
    Mean blood pressure (MBP) (mmHg) were recorded in both groups.

  3. Ease of Placement Laryngeal Mask [ Time Frame: During Laryngeal mask placement ]
    Ease (according to Likert scale 1-4 point from easy to diffucult).

  4. Insertion Time of Laryngeal Mask [ Time Frame: During placement of Laryngeal Mask ]
    Duration of insertion (second) Laryngeal Mask;second



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219282


Locations
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Turkey
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Izmi̇r, Narlıdere, Turkey, 35320
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Study Director: SEMİH KUCUKGUCLU, M.D. Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
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Responsible Party: Sule Ozbilgin, Anaesthesiology and Reanimation, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT02219282    
Other Study ID Numbers: 2010/08-15
First Posted: August 18, 2014    Key Record Dates
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017
Last Verified: May 2017
Keywords provided by Sule Ozbilgin, Dokuz Eylul University:
laryngeal mask airway, edentulate geriatric patients