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Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients

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ClinicalTrials.gov Identifier: NCT02189954
Recruitment Status : Completed
First Posted : July 15, 2014
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Sule Ozbilgin, Dokuz Eylul University

Brief Summary:

Laryngeal Mask is widely used for air-way management during anaesthesia. Pharyngolaryngeal morbidity linked to laryngeal mask use is related to correct choice of mask size, placement technique, placement of the laryngeal mask in the correct position on the larynx, cuff volume and cuff pressure. It has been stated that keeping laryngeal mask cuff pressure below 45 mmHg (60 centimeter of water(cmH2O) ) can prevent pharyngolaryngeal morbidity related to laryngeal mask (throat pain, dysphonia, dysphagia) and shown that using a manometer after Laryngeal Mask Unique placement to limit pressure within the cuff can reduce this morbidity by nearly 70%. Studies commenting on pharyngolaryngeal morbidity generally do not choose a certain age group and cover stages including very young and middle-aged groups. In the literature only one similar study on the geriatric age group was found.

The aim of this study is to compare the postoperative pharyngolaryngeal morbidity in a group with cuff pressure held to 44 mmHg (60 cmH2O with a manometer and a group with Laryngeal Mask cuff inflated without reference to pressure in the geriatric age group with indications for Laryngeal Mask Unique placement.


Condition or disease Intervention/treatment Phase
Anaesthesia Procedure: The placement according to the manufacturer's instructions Procedure: Cuff inner pressure was held below 44 mmHg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Effect of Laryngeal Mask Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Geriatric Patients
Study Start Date : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Active Comparator: Group Routine Care
The placement according to the manufacturer's instructions.
Procedure: The placement according to the manufacturer's instructions
Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®(LMU)) 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 five years experience

Experimental: Group Pressure Limiting
Cuff inner pressure was held below 44 mmHg
Procedure: Cuff inner pressure was held below 44 mmHg
cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)




Primary Outcome Measures :
  1. Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour [ Time Frame: Postoperative 1.hour ]
    The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour


Secondary Outcome Measures :
  1. Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour [ Time Frame: Postoperative 24.hour ]
    The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour



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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
  • Dementia

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): NCT02189954


Locations
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Turkey
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Izmi̇r, Turkey, 35320
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Principal Investigator: FERİM GÜNENÇ, 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: NCT02189954    
Other Study ID Numbers: 269-GOA
First Posted: July 15, 2014    Key Record Dates
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015
Last Verified: August 2015
Keywords provided by Sule Ozbilgin, Dokuz Eylul University:
elderly; laryngeal masks; postoperative complications