Geriatric Patients and Laryngeal Mask Unique

NCT02219282 | Completed Results

• 1 other identifier: 2010/08-15
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthesia

Keywords

laryngeal mask airway, edentulate geriatric patients

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (4)

• Oropharyngeal Leak Pressure

  Baseline

• Haemodynamic Response to Insertion of Airway Device.

  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

  During Laryngeal mask placement

• Insertion Time of Laryngeal Mask

  During placement of Laryngeal Mask

Study Arms (2)

Group Dentulous

ACTIVE COMPARATOR

Laryngeal Mask Unique insertion

Other: Laryngeal Mask Unique insertion

Group Edentulous

EXPERIMENTAL

Laryngeal Mask Unique insertion

Other: Laryngeal Mask Unique insertion

Interventions

Laryngeal Mask Unique insertion OTHER

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.

Group Dentulous; Group Edentulous

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Izmi̇r, Narlıdere, 35320, Turkey (Türkiye)

Location

Results Point of Contact

• Title: Semih Kucukguclu
• Organization: DorkuzEU

semih.kucukguclu@gmail.com

902324125707

Study Officials

• SEMİH KUCUKGUCLU, M.D.

  Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiology and Reanimation

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-05

Locations

TU (1)