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Clinical Trials/NCT02189954
NCT02189954CompletedPhase 4

Effect of Laryngeal Mask Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Geriatric Patients

Dokuz Eylul University2 sites in 1 country90 target enrollmentStarted: July 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
90
Locations
2
Primary Endpoint
Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour

Study Overview

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.

Detailed Description

This study received permission from Dokuz Eylül University Medical Faculty Non-Interventional Ethics Committee and informed consent was obtained from the patients. Ninety patients above the age of 65 with American Society of Anesthesiologists (ASA) physiological classification group I-III, undergoing elective surgery and with indications for laryngeal mask placement participated in this prospective, randomized and double blind study.

Patients taken to the operating room were given standard monitoring (ECG, pulse oxymetry, non-invasive blood pressure) and BIS monitoring [BIS-Vista ™ (Aspect Medical Systems, USA)] before anesthesia induction.

After patients were preoxygenated with 6 L/min oxygen through a face mask for 3 minutes anesthesia induction was provided by 0.02 mg/kg midazolam, 1-2 µg/kg fentanyl and 1-2 mg/kg propofol. During respiration Airway was not used, unless there was ventilation difficulty with the face mask. 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 bispectral index (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. The placement method was according to the manufacturer's instructions. All patients were respirated by a breathing circuit with heat and moisture filter.

After the laryngeal mask was inserted the cases were manually respirated so peak inspiratory pressure was less than 20 cmH2O and the cuff of both groups was inflated with a 20 ml injector until the leak sound ceased. To evaluate ventilation the capnogram showed square wave forms and the patients' chest movements were observed, in unsuccessful situations the procedure was repeated. During attempts depending on the patients' reactions and with the requirement of keeping BIS values between 40 and 60, an additional dose of 0.5 mg/kg propofol was administered.

After Laryngeal Mask was determined and when anesthetic depth was sufficient (BIS 40-60) the inner pressure of the LMU cuff was measured and recorded by a manometer (cuff pressure manometer, Rusch, Germany). Later groups were divided in two using a random number table. In the group with cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg), while the routine group (Group Routine Care, n=45) pressure was only recorded.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour(Postoperative 24.hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sule Ozbilgin

Anaesthesiology and Reanimation

Dokuz Eylul University

Study Sites (2)

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