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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

Tracking Information
First Submitted Date  ICMJE June 28, 2014
First Posted Date  ICMJE July 15, 2014
Results First Submitted Date  ICMJE April 26, 2015
Results First Posted Date  ICMJE August 31, 2015
Last Update Posted Date August 31, 2015
Study Start Date  ICMJE July 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour [ Time Frame: Postoperative 1.hour ]
The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert's scale (none, slight, moderate and severe) at postoperative 1.hour
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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's scale (none, slight, moderate and severe) at postoperative 24.hour
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients
Official Title  ICMJE Effect of Laryngeal Mask Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Geriatric Patients
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.

Anesthesia was maintained by 50% O2:50% air mix with 1.5-2.5% sevoflurane, with sevoflurane concentration and additional fentanyl doses arranged to keep BIS between 40 and 60. All patients were respirated with positive pressure ventilation tidal volume 7-8 ml/kg, inspiring: expiring rate 1:2, respiration frequency on the capnograph end tidal carbon dioxide held between 30-35 mmHg. Oropharyngeal leak pressure measurement was recorded as the pressure value when a leak sound was heard from the mouth after the expiring valve was closed and fresh gas flow was reduced to 3 L/min. Immediately after the laryngeal mask was inserted, every 5 minutes in the first half hour and every 15 minutes after that, tidal volume, mean airway pressure, end tidal carbon dioxide levels and peripheral oxygen saturation values were recorded. If the operation lasted more than one hour a second manometric measurement was taken and stable values were maintained.

After the operation, the LMU's were removed when the patients were awake and could open their mouths on an oral command and unless necessary, aspiration was not applied.After anesthesia the patients were monitored in the recovery unit and analgesia was provided by 5-10 mg intravenous dolantin titration. A researcher blind to the groups recorded throat pain, voice loss and difficulty swallowing in the 1st and 24th hour, classifying as Likert scale ranges from 1 (none) to 4 (severe). Cases developing rare complications of recurrent laryngeal nerve, hypoglossal nerve and lingual nerve paralysis were recorded. The cases were brought to the ward when Aldrete scoring criteria were appropriate. Cases discharged early from the ward had 24th hour evaluation by telephone communication.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Anaesthesia
Intervention  ICMJE
  • 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
  • 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)
Study Arms  ICMJE
  • Active Comparator: Group Routine Care
    The placement according to the manufacturer's instructions.
    Intervention: Procedure: The placement according to the manufacturer's instructions
  • Experimental: Group Pressure Limiting
    Cuff inner pressure was held below 44 mmHg
    Intervention: Procedure: Cuff inner pressure was held below 44 mmHg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2014)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189954
Other Study ID Numbers  ICMJE 269-GOA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sule Ozbilgin, Dokuz Eylul University
Study Sponsor  ICMJE Dokuz Eylul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: FERİM GÜNENÇ, M.D. Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
PRS Account Dokuz Eylul University
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP